The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not

Size: px
Start display at page:

Download "The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not"

Transcription

1 The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product. Before prescribing any product mentioned in this Register, healthcare professionals should consult prescribing information for the product approved in their country. GSK Medicine: GSK GR GI Study Number: ING Title: An Evaluation of the Bioequivalence of a Combined Formulated Tablet (50mg/600mg/300mg dolutegravir/abacavir/lamivudine) Compared to One Dolutegravir 50mg Tablet and One EPZICOM (600mg/300mg abacavir/lamivudine) Tablet Administered Concurrently and the Effect of Food on Bioavailability of the Combined Formulation in Healthy Adult Subjects Rationale: GSK (dolutegravir, DTG) is a next-generation integrase inhibitor (INI) currently under clinical development. Fixed-dose combinations (s) have greatly simplified the treatment of patients with HIV, and a tablet of DTG plus abacavir (ABC; GI265235) and lamivudine (3TC; GR109714) is an attractive treatment option. This was a two-part study, with Part A conducted to evaluate bioequivalence between an tablet formulation of DTG 50mg, ABC 600mg, and 3TC 300mg compared with separate tablet co-administration of DTG 50mg plus the marketed tablet formulation of EPZICOM (ABC 600mg + 3TC 300mg), and with Part B conducted to assess the effect of a high fat meal on the bioavailability of the tablet. Phase: Phase I Study Period: 20 June September 2012 Study Design: This was a single center, randomized, two-part, open-label, crossover study in healthy adult subjects to evaluate the bioequivalence of a single combined formulated tablet of DTG 50mg, ABC 600mg and 3TC 300mg compared to co-administration of the separate tablet formulations of DTG 50mg and EPZICOM (EPZ) in the state, and to evaluate the effect of food on the bioavailability of the combined formulation. The study consisted of screening, treatment and follow-up phases. The treatment phase was divided into two parts (Part A and Part B). Part A consisted of 2 single dose treatment sequences (AB, BA) in a randomized, two-period, crossover design, with a 7 day washout between doses. Twelve subjects who completed Part A participated in Part B and received a single dose of the combined formulated tablet administered with a high fat meal ( C). There was a 7 day washout between the second dose in Part A and the dose in Part B. The follow-up phase was scheduled for 7 to 14 days post last dose of study drug. Center: 1 center in the United States Indication: HIV-1 s: A tablet, DTG 50 mg/abc 600 mg/3tc 300 mg tablet, B DTG+EPZ, DTG 50 mg tablet plus a single EPZICOM tablet, C tablet, DTG 50 mg/abc 600 mg/3tc 300 mg tablet with a high fat meal Objectives: The primary objective was to evaluate the bioequivalence between a single fixed dose combination () tablet formulation of DTG 50mg, ABC 600mg and 3TC 300mg versus co-administration of the separate tablet formulations of DTG 50mg plus EPZICOM (ABC 600mg / 3TC 300mg), with each dose given in the state. Primary Outcome Variable: The primary endpoints were plasma DTG, ABC, and 3TC pharmacokinetic (PK) parameters: area under the concentration time curve from time zero (pre-dose) to the time of the last quantifiable concentration (AUC(0-t)), area under the plasma concentration curve from time zero (pre-dose) extrapolated to infinity (AUC(0- )) and maximum observed plasma concentration (Cmax). Secondary Outcome Variables: The secondary endpoints included safety and tolerability parameters as assessed by change from baseline in 12-lead electrocardiogram (ECG) and vital signs (blood pressure [BP] and heart rate [HR]), and number of subjects with adverse events and toxicity grading of clinical laboratory tests. Other secondary endpoints included additional PK parameters: lag time before observation of drug concentration in plasma (tlag), time of occurrence of Cmax (tmax), terminal phase half-life (t1/2), apparent clearance (CL/F), apparent volume of distribution (Vz/F), and DTG concentration 24 hours post dose administration (C24). Statistical Methods: Frequent sampling up to 48 hours was performed after each treatment dose for assay of DTG, ABC and 3TC concentrations in plasma and subsequent determination of associated PK parameters by standard noncompartmental methods. Bioequivalence (BE) assessment included data from Part A only. Following loge-transformation, the PK parameters Cmax, AUC(0-t), AUC(0- ), t1/2, CL/F, and Vz/F for DTG, ABC and 3TC were separately analyzed using a mixed effects analysis of variance (ANOVA) model with fixed effect terms for Sequence, Period and, and with Subject treated as a random effect. Point estimates and their associated 90% confidence intervals (CIs) were 1

2 constructed for the differences, test treatment (A) reference treatment (B), and were then back-transformed to provide point estimates and 90% CIs for the ratios, test/reference, on the original scale. Food effect assessment included data from the subset of subjects who received both A in Part A and C in Part B. The statistical analysis for food effect was the same as that for BE assessment except that was the only fixed effect term included in the ANOVA model. Study Population: Healthy subjects between 18 and 55 years of age inclusive, body weight 50 kg (110 lbs) for males and 45 kg (99 lbs) for females, body mass index (BMI) 18.5 to 31 kg/m 2 (inclusive), and with negative HLA-B*5701 allele at the screening assessment. Part A Part B Number of Subjects: Fasted DTG + EPZ Fasted Overall Fed Planned, N Randomized, N Completed, n (%) 63 (97) 62 (95) 61 (92) 12 (100) Total Number Subjects Withdrawn, N (%) 2 (3) 3 (5) 5 (8) 0 Withdrawn due to Adverse Events n (%) 1 (2) 0 1 (2) 0 Lost to follow-up 0 1 (2) 1 (2) 0 Investigator discretion 1 (2) 2 (3) 3 (5) 0 Demographics Part A Part B Fasted Fed (N=12) N (Safety Population) Females: Males 22: 43 22: 43 4: 8 Mean Age, years (SD) 29.3 (9.59) 29.3 (9.55) 33.8 (11.06) White, n (%) 34 (52) 34 (52) 7 (58) SD=Standard deviation Pharmacokinetic Results: In study Part A, 62 subjects received both treatments ( and DTG+EPZ ) and provided evaluable PK parameters. In study Part B, 12 subjects who participated in Part A received the tablet with a high fat meal. Study Part A: Plasma DTG, ABC, and 3TC Pharmacokinetic s for Bioequivalence Assessment 1 Summary of Plasma DTG Pharmacokinetic s 1 DTG PK Fasted AUC(0- ) ( g.h/ml) 44.8 (33) 47.4 (34) AUC(0-t) ( g.h/ml) 40.9 (31) 43.4 (32) Cmax ( g/ml) 2.44 (28) 2.54 (29) C24 ( g/ml) 0.73 (35) 0.76 (38) CL/F (L/hr) 1.12 (33) 1.05 (34) t1/2 (h) 12.8 (20) 12.9 (18) tlag (h) (0.0, 0.5) (0.0, 0.5) tmax (h) 3.00 (1.0, 8.0) 3.00 (0.5, 8.0) Vz/F (L) 20.5 (28) 19.6 (32) 2

3 Summary of Plasma ABC Pharmacokinetic s 1 ABC PK Fasted AUC(0- ) ( g.h/ml) 13.9 (26) 14.5 (24) AUC(0-t) ( g.h/ml) 13.9 (26) 14.5 (24) Cmax ( g/ml) 4.02 (24) 4.37 (26) CL/F (L/hr) 43.1 (26) 41.4 (24) t1/2 (h) 2.56 (32) 2.54 (27) tlag (h) (0.0, 0.5) tmax (h) 2.00 (0.5, 3.0) 2.00 (0.5, 5.0) Vz/F (L) 159 (36) 151 (34) Summary of Plasma 3TC Pharmacokinetic s 1 3TC PK Fasted AUC(0- ) ( g.h/ml) 12.8 (25) 13.1 (21) AUC(0-t) ( g.h/ml) 12.3 (26) 12.8 (21) Cmax ( g/ml) 2.11 (29) 2.28 (26) CL/F (L/hr) 23.5 (25) 22.9 (21) t1/2 (h) 14.5 (53) 12.7 (41) tlag (h) tmax (h) 3.00 (1.0, 5.0) 2.00 (1.0, 4.0) Vz/F (L) 492 (64) 420 (44) Study Part B: Plasma DTG, ABC, and 3TC Pharmacokinetic s for Food Effect Assessment 1 Compound and DTG ABC 3TC PK AUC(0- ) ( g.h/ml) 40.5 (35) 60.1 (27) 13.0 (31) 12.0 (32) 12.1 (34) 12.6 (29) AUC(0-t) ( g.h/ml) 37.4 (32) 54.9 (24) 12.9 (31) 12.0 (32) 11.6 (37) 12.2 (30) Cmax ( g/ml) 2.25 (25) 3.08 (20) 3.84 (23) 2.97 (39) 1.95 (41) 1.87 (33) CL/F (L/hr) 1.23 (35) 0.83 (27) 46.3 (31) 50.0 (32) 24.8 (34) 23.8 (29) t1/2 (h) 12.4 (16) 12.7 (15) 2.23 (27) 2.76 (32) 15.2 (66) 16.3 (37) tlag (h) 0.25 (0.0, 0.5) tmax (h) 3.00 (1.0, 5.0) 4.50 (2.0, 8.0) 2.00 (0.5, 3.0) 3.00 (2.0, 5.0) 3.00 (1.0, 4.0) 3.50 (2.0, 6.0) Vz/F (L) 22.0 (23) 15.2 (19) 149 (33) 199 (40) 544 (86) 559 (52) 3

4 Statistical Results: Study Part A: Statistical Comparison of Selected Plasma PK s for Bioequivalence Assessment Ratio of GLS Means [90% CI] Fasted vs DTG PK s AUC(0- ) [0.889, 1.00] AUC(0-t) [0.888, 1.00] Cmax [0.906, 1.02] ABC PK s AUC(0- ) [0.939, 0.980] AUC(0-t) [0.939, 0.980] Cmax [0.867, 0.977] 3TC PK s AUC(0- ) [0.940, 1.01] AUC(0-t) [0.928, 0.994] Cmax [0.885, 0.968] GLS=Geometric least squares Study Part B: Statistical Comparison of Selected Plasma PK s for Food Effect Assessment Ratio of GLS Means [90% CI] Fed vs Fasted DTG PK s AUC(0- ) 1.48 [1.36, 1.62] AUC(0-t) 1.47 [1.35, 1.60] Cmax 1.37 [1.26, 1.48] ABC PK s AUC(0- ) [0.899, 0.953] AUC(0-t) [0.898, 0.952] Cmax [0.662, 0.905] 3TC PK s AUC(0- ) 1.04 [0.971, 1.12] AUC(0-t) 1.05 [0.963, 1.14] Cmax [0.879, 1.05] GLS=Geometric least squares Safety Results: Adverse events (AEs) and serious adverse events (SAEs) were collected and recorded in the CRF from Period 1, Day 1 through the follow-up visit (7-14 days after the last dose of study drug). Only SAEs related to study participation (e.g. invasive procedures) were recorded prior to dosing with investigational product. Adverse events occurring in 2 or more subjects in any treatment group in Part A are summarized below. No AE was reported for Part B of the study. Fasted Subjects with any AE(s), n(%) 26 (40%) 25 (38%) Nausea 11 (17%) 19 (29%) Headache 4 (6%) 5 (8%) Somnolence 5 (8%) 2 (3%) Abdominal pain 0 2 (3%) : Fasted=DTG 50 mg/abc 600 mg/3tc 300 mg tablet DTG + EPZ =DTG 50 mg tablet plus a single EPZICOM tablet Serious Adverse Events - On-Therapy: No deaths or SAEs were reported during the study. 4

5 Conclusion: Dosing with EPZ +DTG and were well tolerated and demonstrated similar tolerability during Part A. Dosing of the tablet with a high fat meal was well tolerated during Part B. Bioequivalence was demonstrated between the tablet formulation and the separate co-administered tablet formulations of DTG plus EPZICOM. Administration of the tablet with a high fat meal resulted in increases in plasma DTG Cmax and AUC, but these are not considered clinically significant. The effects of food on ABC and 3TC exposures were very similar to prior effects seen with EPZICOM, which may be taken with or without food. These results support the recommendation that the tablet can be given without regard to meals. 5

PFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See USPI

PFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See USPI PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.

More information

Japanese, Korean and Chinese subjects had also lived outside their respective countries for less than 10 years.

Japanese, Korean and Chinese subjects had also lived outside their respective countries for less than 10 years. The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall

More information

Study No Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objectives: Study Endpoints: Pharmacokinetics:

Study No Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objectives: Study Endpoints: Pharmacokinetics: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives:

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of the clinical

More information

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment:

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not

The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of the clinical

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the

More information

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall

More information

The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not

The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Subjects from the Safety Population who had GSK PK parameter estimates from any portion of the study. Cohort 1 (N=8)

Subjects from the Safety Population who had GSK PK parameter estimates from any portion of the study. Cohort 1 (N=8) The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical

More information

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives:

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Study Centers: This study was conducted in 2 centers in Italy.

Study Centers: This study was conducted in 2 centers in Italy. Title of Trial: A randomised, double-blind, placebo-controlled, two-period, two-sequence-crossover interaction study to assess the effect of safinamide on levodopa pharmacokinetics in subjects with Parkinson

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of the clinical

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of

More information

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall

More information

HM2008/00566/00. study and to obtain clinical experience with the use of this drug. Primary Outcome/Efficacy Variable(s): <Pharmacokinetics>

HM2008/00566/00. study and to obtain clinical experience with the use of this drug. Primary Outcome/Efficacy Variable(s): <Pharmacokinetics> The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall

More information

Study No: LOV OMA-104 Title : Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Statistical Methods

Study No: LOV OMA-104 Title : Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Statistical Methods The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Treatment A Placebo to match COREG CR 20 mg OD + Lisinopril 10 mg OD (Days 1-7) Placebo to match COREG CR 40 mg OD + Lisinopril 10 mg OD (Days 8-14)

Treatment A Placebo to match COREG CR 20 mg OD + Lisinopril 10 mg OD (Days 1-7) Placebo to match COREG CR 40 mg OD + Lisinopril 10 mg OD (Days 8-14) The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

SYNOPSIS. Number of subjects: Planned: 22 Randomized: 23 Treated: 23. Evaluated: Pharmacodynamic: 22 Safety: 23 Pharmacokinetics: 22

SYNOPSIS. Number of subjects: Planned: 22 Randomized: 23 Treated: 23. Evaluated: Pharmacodynamic: 22 Safety: 23 Pharmacokinetics: 22 SYNOPSIS Title of the study: A randomized, cross-over, open, euglycemic clamp study on the relative bioavailability and activity of 0.6 U/kg insulin glargine and 20 µg lixisenatide, given as on-site mix

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of the clinical

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of

More information

Sponsor / Company: Sanofi Drug substance: SAR236553/REGN727 (alirocumab)

Sponsor / Company: Sanofi Drug substance: SAR236553/REGN727 (alirocumab) These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor / Company: Sanofi Drug substance:

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Sponsor: Sanofi Drug substance(s): SAR342434

Sponsor: Sanofi Drug substance(s): SAR342434 These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor: Sanofi Drug substance(s):

More information

mg 25 mg mg 25 mg mg 100 mg 1

mg 25 mg mg 25 mg mg 100 mg 1 The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the

More information

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives:

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Results. Subject Disposition and Demographics Of 37 enrolled subjects, 23 (62.2%) completed the study

Results. Subject Disposition and Demographics Of 37 enrolled subjects, 23 (62.2%) completed the study Poster 5-20 Effect of Gastric ph on the Bioavailability of in Healthy Subjects James Longstreth, PhD, Marijke H. Adams, PharmD, PhD, 2 Vasi Sperry, PhD, 3 Dan Kajdasz, PhD, 3 Carol R. Reed, MD 3 Longstreth

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives:

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Study No: Title : Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Statistical Methods: Sample Size

Study No: Title : Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Statistical Methods: Sample Size The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Study No: Title : Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Statistical Methods:

Study No: Title : Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Statistical Methods: Study No: MNK111587 Title : A healthy volunteer repeat dose study to evaluate; the safety, tolerability, pharmacokinetics, effects on the pharmacokinetics of midazolam and the neurokinin-1 (NK1) receptor

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

TRIUMEQ * (DTG/ABC/3TC): BIOEQUIVALENCE DATA

TRIUMEQ * (DTG/ABC/3TC): BIOEQUIVALENCE DATA TRIUMEQ * (DTG/ABC/3TC): BIOEQUIVALENCE DATA *In studies supporting TRIUMEQ, DTG 50 mg + ABC 600 mg/3tc 300 mg were used. Bioequivalence has been demonstrated. DTG, dolutegravir; ABC, abacavir; 3TC, lamivudine

More information

Principal Investigator: Marion, Alan, S, M.D., MDS Pharma Services (US) Inc., 621 Rose Street, PO Box 80837, Lincoln, NE 68502, USA

Principal Investigator: Marion, Alan, S, M.D., MDS Pharma Services (US) Inc., 621 Rose Street, PO Box 80837, Lincoln, NE 68502, USA SYNOPSIS Issue Date: 06 October 2008 Document No.: EDMS-PSDB-8954363:2. Name of Sponsor/Company Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Name of Finished Product Name of Active Ingredient(s)

More information

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives:

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the

More information

Product: Cinacalcet hydrochloride Clinical Study Report: Page 2 of 670

Product: Cinacalcet hydrochloride Clinical Study Report: Page 2 of 670 Page 2 of 670 2. SYNOPSIS Name of Sponsor: mgen Inc., Thousand Oaks, C Name of Finished Product: Cinacalcet hydrochloride (Sensipar, Mimpara ) Name of ctive Ingredient: cinacalcet (cinacalcet hydrochloride

More information

Final Report (Amendment 1) April 11, 2006 Page 4 of 50

Final Report (Amendment 1) April 11, 2006 Page 4 of 50 Page 4 of 50 2 SYNOPSIS Title: A Bioavailability Study to Assess the Bioequivalence of Alfacalcidol Capsule and Oral Drop Formulations: A Comparative, Randomized, Single-Dose, 4-Way Crossover Bioavailability

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of

More information

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall

More information

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall

More information

BRL /RSD-101RLL/1/CPMS-716. Report Synopsis

BRL /RSD-101RLL/1/CPMS-716. Report Synopsis Report Synopsis Study Title: A Multicenter, Open-label, Six-Month Extension Study to Assess the Long-term Safety of Paroxetine in Children and Adolescents with Major Depressive Disorder (MDD) or Obsessive-Compulsive

More information

090177e182b31c5d\0.1\Draft\Versioned On:16-Dec :12

090177e182b31c5d\0.1\Draft\Versioned On:16-Dec :12 MAH: / Product: IBU/PSE Protocol Number EudraCT number (if applicable) Trial report number PMID / D.O.I. (if applicable) Date of trial Is the trial Trial design Background for conducting the trial Participants

More information

The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not

The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of

More information

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. SYNOPSIS Issue Date: 27 April 2009 Document No.: EDMS-PSDB-9908562:2.0 Name of Sponsor/Company Name of Finished Product Name of Active Ingredient Johnson & Johnson Pharmaceutical Research & Development,

More information

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objective:

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objective: GSK Medicine: abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) Study Number: 201147 Title: A IIIb, randomized, open-label study of the safety, efficacy, and tolerability of switching to a fixed-dose

More information

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall

More information

Kimberly Adkison, 1 Lesley Kahl, 1 Elizabeth Blair, 1 Kostas Angelis, 2 Herta Crauwels, 3 Maria Nascimento, 1 Michael Aboud 1

Kimberly Adkison, 1 Lesley Kahl, 1 Elizabeth Blair, 1 Kostas Angelis, 2 Herta Crauwels, 3 Maria Nascimento, 1 Michael Aboud 1 Pharmacokinetics of Dolutegravir and Rilpivirine After Switching to the Two-Drug Regimen From an Efavirenz- or Nevirapine- Based Antiretroviral Regimen: SWORD-1 & -2 Pooled PK Analysis Kimberly Adkison,

More information

SYNOPSIS. Issue Date: 31 July 2013

SYNOPSIS. Issue Date: 31 July 2013 SYNOPSIS Issue Date: 31 July 2013 Name of Sponsor/Company Name of Finished Product Name of Active Ingredient(s) Janssen Research & Development, LLC YONDELIS Trabectedin (R279741) Protocol No.: ET743-OVC-1003

More information

Individual Study Table Referring to Part of the Dossier. Volume:

Individual Study Table Referring to Part of the Dossier. Volume: Final Report M/100977/21Final Version () 2. SYNOPSIS A Title of Study: A PHASE IIa, RANDOMISED, DOUBLE-BLIND, MULTIPLE DOSE, PLACEBO CONTROLLED, 3 PERIOD CROSS-OVER, ASCENDING DOSE CLINICAL TRIAL TO ASSESS

More information

Sponsor: Sanofi Drug substance(s): GZ316455

Sponsor: Sanofi Drug substance(s): GZ316455 These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor: Sanofi Drug substance(s):

More information

Dr. M.Mothilal Assistant professor

Dr. M.Mothilal Assistant professor Dr. M.Mothilal Assistant professor Bioavailability is a measurement of the rate and extent of drug that reaches the systemic circulation from a drug product or a dosage form. There are two different types

More information

Study No Title : Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment:

Study No Title : Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

These results are supplied for informational purposes only.

These results are supplied for informational purposes only. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: sanofi-aventis ClinialTrials.gov

More information

PFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See USPI.

PFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See USPI. PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Pharmacokinetic Interaction Between Norgestimate/Ethinyl Estradiol and EVG/COBI/FTC/TDF Single Tablet Regimen

Pharmacokinetic Interaction Between Norgestimate/Ethinyl Estradiol and EVG/COBI/FTC/TDF Single Tablet Regimen Pharmacokinetic Interaction Between Norgestimate/Ethinyl Estradiol and EVG/COBI/FTC/TDF Single Tablet Regimen Polina German, Maggie Wang, David Warren and Brian Kearney Gilead Sciences Foster City, CA,

More information

Referring to Part IV of the Dossier

Referring to Part IV of the Dossier 2. SYNOPSIS Name of Company: Mundipharma Research Limited Name of Finished Product: FlutiForm Name of Active Ingredient: Fluticasone propionate / Formoterol fumarate INDIVIDUAL STUDY TABLE Referring to

More information

This was a randomized, double-blind, placebo-controlled, fixed-dose, parallel-group study.

This was a randomized, double-blind, placebo-controlled, fixed-dose, parallel-group study. The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Ph D. Synopsis 4. WORK PLAN AND METHODOLOGY

Ph D. Synopsis 4. WORK PLAN AND METHODOLOGY 4. WORK PLAN AND METHODOLOGY WORK PLAN FOR BIOEQUIVALENCE STUDY OF TOPIRAMATE 1. Literature Review 2. Fasting Bioequivalence Study Clinical Phase Preparation of Clinical study Protocol Recruitment of Volunteers

More information

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable: Study No.: 29060/717 Title: A Double-Blind, Placebo-Controlled, 3-Arm, Fixed-Dose Study of CR Intermittent Dosing (12.5 mg and 25 mg) for Premenstrual Dysphoric Disorder Rationale: In most trials investigating

More information

PUBLIC ASSESSMENT REPORT Scientific Discussion

PUBLIC ASSESSMENT REPORT Scientific Discussion Direction de l Evaluation des Médicaments et des Produits Biologiques PUBLIC ASSESSMENT REPORT Scientific Discussion Tramadol hydrochloride + paracetamol 37.5 mg-325 mg Grünenthal film coated tablets Bonoc

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Treatment B: FF (400 µg) and UMEC (250 µg)/vi(100 µg) The indicated dose is the total of four inhalations via the dry powder inhaler.

Treatment B: FF (400 µg) and UMEC (250 µg)/vi(100 µg) The indicated dose is the total of four inhalations via the dry powder inhaler. GSK Medicine:GSK573719 (Umeclidinium)+ GW6424 (Vilanterol) + GW685698 (Fluticasone furoate) Study Number: 200587 Title: An open label, randomised, four-period crossover, single dose study in healthy volunteers

More information

Study Population: 12 years and older A EF Calcipotriene Foam, 0.005%

Study Population: 12 years and older A EF Calcipotriene Foam, 0.005% Study No.: CAL.203 Title: A Randomized, Open-Label Study to Assess the Bioavailability of Emulsion Formulation Foam, 0.005%, and Dovonex, 0.005%, in Patients with Mild to Moderate Plaque-Type Psoriasis

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

SYNOPSIS Final Clinical Study Report for Study AI444031

SYNOPSIS Final Clinical Study Report for Study AI444031 Name of Sponsor/Company: Bristol-Myers Squibb Name of Finished Product: Name of Active Ingredient: () Individual Study Table Referring to the Dossier (For National Authority Use Only) SYNOPSIS for Study

More information

SINGLE-DOSE AND STEADY-STATE PHARMACOKINETICS OF MOXDUO, A DUAL-OPIOID FORMULATION CONTAINING A FIXED RATIO OF MORPHINE AND OXYCODONE

SINGLE-DOSE AND STEADY-STATE PHARMACOKINETICS OF MOXDUO, A DUAL-OPIOID FORMULATION CONTAINING A FIXED RATIO OF MORPHINE AND OXYCODONE #298 SINGLE-DOSE AND STEADY-STATE PHARMACOKINETICS OF MOXDUO, A DUAL-OPIOID FORMULATION CONTAINING A FIXED RATIO OF MORPHINE AND OXYCODONE LYNN WEBSTER, MD; 1 JOEL OWEN, PHD, RPH; 2 INGER DARLING, PHD;

More information

Principal Investigator: Robert J. Jones, MD, Beatson Cancer Center, 1053 Great Western Road, Glasgow; United Kingdom

Principal Investigator: Robert J. Jones, MD, Beatson Cancer Center, 1053 Great Western Road, Glasgow; United Kingdom SYNOPSIS Issue Date: 14 October 2010 Document No.: EDMS-ERI-13494974:2.0 Name of Sponsor/Company Name of Finished Product Name of Active Ingredient(s) Protocol No.: COU-AA-BE Cougar Biotechnology, Inc.

More information

PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert.

PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. Public Disclosure Synopsis Protocol A7772 September 25 Final PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert.

More information

INDIVIDUAL STUDY TABLE REFERRING TO PART OF THE DOSSIER

INDIVIDUAL STUDY TABLE REFERRING TO PART OF THE DOSSIER 2. SYNOPSIS Title of Study: An Open-Label, 2-Cohort Study to Evaluate the 2-Way Interaction Between Multiple Doses of and a Single Dose of Rosuvastatin (Crestor ), to Assess the Dose Proportionality of,

More information

PFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See United States Package Insert (USPI)

PFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See United States Package Insert (USPI) PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.

More information

ABC/3TC/ZDV ABC PBO/3TC/ZDV

ABC/3TC/ZDV ABC PBO/3TC/ZDV The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

BRL /RSD-101C0F/1/CPMS-716. Report Synopsis

BRL /RSD-101C0F/1/CPMS-716. Report Synopsis Report Synopsis Study Title: A Multicenter, Open-label, Six-Month Extension Study to Assess the Long-Term Safety of Paroxetine in Children and Adolescents with Major Depressive Disorder (MDD) or Obsessive-Compulsive

More information

Lack of pharmacokinetic interaction between the oral anti-influenza neuraminidase inhibitor prodrug oseltamivir and antacids

Lack of pharmacokinetic interaction between the oral anti-influenza neuraminidase inhibitor prodrug oseltamivir and antacids Blackwell Science, Ltdxford, UKBJCPBritish Journal of Clinical Pharmacology0306-5251Blackwell Science, 200254riginal Articleseltamivir and antacids lack of kinetic interactionp. Snell et al. Lack of pharmacokinetic

More information

Study No.:MPX Title: Rationale: Phase: IIB Study Period: Study Design: Centres: Indication: Treatment: Objectives:

Study No.:MPX Title: Rationale: Phase: IIB Study Period: Study Design: Centres: Indication: Treatment: Objectives: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

INDIVIDUAL STUDY TABLE REFERRING TO PART OF THE DOSSIER Volume: Page:

INDIVIDUAL STUDY TABLE REFERRING TO PART OF THE DOSSIER Volume: Page: SYNOPSIS Protocol No.: CR004357 Title of Study: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 50 and 100 mg eq. of Paliperidone Palmitate in Subjects With

More information

BRL /RSD-101C0D/1/CPMS-704. Report Synopsis

BRL /RSD-101C0D/1/CPMS-704. Report Synopsis Report Synopsis Study Title: A Randomized, Multicenter, 10-Week, Double-Blind, Placebo- Controlled, Flexible-Dose Study to Evaluate the Efficacy and Safety of Paroxetine in Children and Adolescents with

More information

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall

More information

Public Assessment Report Scientific discussion. Anastrozole Bluefish 1 mg film-coated tablets (anastrozole) SE/H/781/01/DC

Public Assessment Report Scientific discussion. Anastrozole Bluefish 1 mg film-coated tablets (anastrozole) SE/H/781/01/DC Public Assessment Report Scientific discussion Anastrozole Bluefish 1 mg film-coated tablets (anastrozole) SE/H/781/01/DC This module reflects the scientific discussion for the approval of Anastrozole

More information

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Principal Investigator and Study Center: F. Nobuoka, MD Ageo Medical Clinic, 3133 Haraichi, Ageo City, Saitama , Japan

Principal Investigator and Study Center: F. Nobuoka, MD Ageo Medical Clinic, 3133 Haraichi, Ageo City, Saitama , Japan Page 1 APPENDIX 9: ZRHM-PK-05-JP CLINICAL STUDY SUMMARY The study was conducted in Japan from August to November 2013. Principles as defined in International Conference on Harmonization (ICH) Good Clinical

More information

Study No.: Title: Rationale: Phase: Study Period: Study Design: Center: Indication: Treatment: Objective: Primary Outcome/Efficacy Variable:

Study No.: Title: Rationale: Phase: Study Period: Study Design: Center: Indication: Treatment: Objective: Primary Outcome/Efficacy Variable: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

(For National Authority Use Only) Name of Study Drug: to Part of Dossier:

(For National Authority Use Only) Name of Study Drug: to Part of Dossier: 2.0 Synopsis Abbott Laboratories Individual Study Table Referring to Part of Dossier: (For National Authority Use Only) Name of Study Drug: Volume: Vicodin CR Name of Active Ingredient: Page: Hydrocodone/Acetaminophen

More information