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

Size: px
Start display at page:

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

Transcription

1 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 study report had been prepared in accordance with best practice and applicable legal and regulatory requirements at the time of study completion. The synopsis may include approved and non approved uses, doses, formulations, treatment regimens and/or age groups; it has not necessarily been submitted to regulatory authorities. A synopsis is not intended to provide a comprehensive analysis of all data currently available regarding a particular drug. More current information regarding a drug is available in the approved labeling information which may vary from country to country.. Additional information on this study and the drug concerned may be provided upon request based on s Policy on Transparency and Publication of Clinical Study Data. The synopsis is supplied for informational purposes only in the interests of scientific disclosure. It must not be used for any commercial purposes and must not be distributed, published, modified, reused, posted in any way, or used for any other purpose without the express written permission of.

2 Page 1 BI Trial No.: of 5 Title of trial: Relative bioavailability of single oral dose of when administered alone or in combination with multiple oral doses of ketoconazole or voriconazole in healthy male subjects (an open-label, randomised, three-period cross-over trial) Principal Investigator: Trial site: Publication (reference): Clinical phase: Objectives: Methodology: Data of this trial have not been published. I The trial investigated the effects of multiple oral doses of ketoconazole or voriconazole on the single oral dose pharmacokinetics (PK) of ; the primary objective was to assess the relative bioavailability of. Randomised, open-label, 3-way crossover intra-individual comparison in healthy male volunteers, single-centre, Phase I No. of subjects: planned: entered: 18 actual: BI (reference): : entered: 20 treated: 18 analysed (for primary PK endpoint): 18 BI + K (test): plus ketoconazole: entered: 20 treated: 19 analysed (for primary PK endpoint): 18 BI + V (test): plus voriconazole: entered: 20 treated: 20 analysed (for primary PK endpoint): 18 Diagnosis and main criteria for inclusion: Healthy male volunteers in the age range of 18 years and 50 years and with a Body Mass Index (BMI) of 18.5 kg/m 2 and 29.9 kg/m 2 were included.

3 Page 2 BI Trial No.: of 5 Test products: doses: mode of admin.: batch nos.: Reference therapy: doses: mode of admin.: batch no.: BI + K: ketoconazole 200 mg tablets; film-coated tablet 25 mg BI + V: voriconazole 200 mg tablets; film-coated tablet 25 mg BI + K: ketoconazole 200 mg bid for 4 days: 25 mg single dose BI + V: voriconazole 400 mg bid loading dose for 1 day, then 200 mg bid for 3 days; 25 mg single dose Oral with 240 ml of water after an overnight fast of at least 10 hours Ketoconazole: ; voriconazole: not applicable; BI: B film-coated tablet 25 mg 25 mg Oral with 240 ml of water BI: B Duration of treatment: BI: (25 mg single dose) for 1 day (Day 1) BI + K: Ketoconazole (200 mg bid) for 4 days (Days -2, -1, 1, and 2) plus (25 mg single dose) for 1 day (Day 1) BI + V: Voriconazole (400 mg bid) for 1 day on Day -2 (loading dose) followed by voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus (25 mg single dose) for 1 day (Day 1) A wash-out period of at least 6 days was respected between the administrations of. Criteria for evaluation: Clinical pharmacology: Primary PK endpoints: AUC 0-tz and C max of Secondary PK endpoints: AUC 0-, t max, and t 1/2 of Other PK endpoints: %AUC tz-, λ z, AUC t1-t2, MRT po, CL/F, Vz/F, further PK parameters as appropriate Safety: All safety endpoints were defined as other endpoints. Safety measures primarily involved the monitoring of adverse events (AEs). Further safety assessments included safety laboratory tests, vital signs (blood pressure [BP], pulse rate [PR]), and 12-lead electrocardiograms (ECGs), as well as physical examinations.

4 Page 3 BI Trial No.: of 5 Statistical methods: SUMMARY CONCLUSIONS: Clinical pharmacology results: To estimate the relative bioavailability, the ratios of geometric means (gmeans) and their two-sided 90% confidence intervals (CIs) were calculated for primary and secondary PK endpoints regarding alone compared with ketoconazole plus and voriconazole plus. The statistical model was an ANOVA on the logarithmic scale including effects for sequence, subjects within sequences, period, and treatment. CIs were calculated based on the residual errors from ANOVA. Moreover, descriptive statistics were calculated for all endpoints. All 20 subjects enrolled were male and of White racial origin. Their mean age was 36.3 years (range: 23 to 50 years) and they had a mean BMI of kg/m 2 (range: 20.9 to 29.0 kg/m 2 ). A total of 18 subjects completed the trial according to protocol, while 2 subjects were withdrawn due to major protocol violations (positive drug screens). Pharmacokinetics The plasma concentration-time profiles of were similarly shaped, whether given alone (BI) or in combination with ketoconazole (BI + K) or voriconazole (BI + V). The table below summarises the most relevant PK parameters of. PK parameters BI N=18 BI + K N=18 BI + V N=18 gmean (gcv%) gmean (gcv%) gmean (gcv%) AUC 0-tz [nmol h/l] 494 (36.7) 1840 (36.9) 1320 (51.4) C max [nmol/l] 102 (55.5) 267 (41.9) 218 (54.0) AUC 0- [nmol h/l] 496 (36.7) 1850 (36.9) 1320 (51.4) 1 t max [h] 1.0 ( ) 1.25 ( ) 1.5 ( ) t 1/2 [h] 11.0 (28.0) 9.20 (18.3) 10.6 (18.8) 1 For t max the median and range (min - max) are given The time to maximum plasma concentration and the terminal half-life of were not relevantly affected by coadministration of ketoconazole or voriconazole.

5 Page 4 BI Trial No.: of 5 Clinical pharmacology results (continued): Safety results: Pharmacokinetics (continued) Coadministration of ketoconazole increased the relative bioavailability of by 374% (90% CI: , ) based on AUC 0-tz, by 373% (90% CI: , ) based on AUC 0-, and by 261% (90% CI: , ) based on C max. Coadministration of voriconazole increased the relative bioavailability of by 267% based on AUC 0-tz (90% CI: , ) and AUC 0- (90% CI: , ) as well as by 213% (90% CI: , ) based on C max. Adverse events The majority of all subjects (80.0%) developed at least one AE. All AEs were of mild to moderate intensity and had resolved at the end of the observation period. Following monotherapy, 16.7% of subjects developed at least one AE and 11.1% of subjects developed at least one drug-related AE. Coadministration with ketoconazole did not increase the incidences of AEs (16.7%) / drug-related AEs (5.6%) compared with given alone, while the combination with voriconazole led to a higher incidence of AEs (26.3%) / drug-related AEs (26.3%). Across all treatments, the incidences of AEs / drug-related AEs were highest during the ketoconazole and voriconazole induction periods prior to the dosing of (ketoconazole: 47.4% / 26.3%; voriconazole: 60.0% / 60.0%). The most frequent SOCs were eye disorders (total incidence 60.0%) followed by nervous system disorders (total incidence 45.0%). On the PT level, photopsia and headache were the most frequently reported AEs. Photopsia occurred only in subjects exposed to voriconazole (incidence 55.0% on voriconazole alone; 5.3% on plus voriconazole). Headache was most frequent during the ketoconazole (26.3%) and voriconazole (15.0%) induction periods compared with alone (5.6%) or in combination with ketoconazole (11.1%) or voriconazole (5.3%). Following monotherapy with, drug-related AEs were abdominal pain and headache in 1 subject each (5.6%). Taking all administration days of together (i.e., given either alone or in combination with ketoconazole or voriconazole), drug-related AEs comprised rhinitis (5.3%), headache (15.8%), photopsia (5.3%), blurred vision (10.5%), and abdominal pain (5.3%).

6 Page 5 BI Trial No.: of 5 Safety results (cont.): Conclusions: Safety laboratory Across all treatments, relevant abnormalities in safety laboratory values were not observed, including clinical chemistry, haematology, coagulation parameters, and urinalysis. Vital signs and 12-lead ECG No clinically relevant changes from baseline were observed in vital signs (BP, PR) or 12-lead ECG. In this randomised, 3-way crossover trial in 20 healthy male subjects, the potent CYP 3A4 and P-gp inhibitor ketoconazole significantly increased the exposure to 25 mg by 3.7 fold (AUC) and by 2.6-fold (C max ). The potent CYP 3A4 inhibitor voriconazole significantly increased the exposure to 25 mg by 2.7-fold (AUC) and by 2.1-fold (C max ). was well tolerated. The increased exposure to following coadministration with ketoconazole or voriconazole did not translate into a higher incidence of AEs associated with the administration of. Photopsia, blurred vision, and insomnia can be reasonably attributed to voriconazole, given its established safety profile. New safety signals precluding the further clinical development of were not identified.

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 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 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

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

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 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

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 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

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

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

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 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 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 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 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

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 Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

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 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

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

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

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

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

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 Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

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 Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

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 Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

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

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

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

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

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

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

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 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 Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

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

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

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 Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

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

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 Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

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 Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

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

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

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

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

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

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

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. 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

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 Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

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

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

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

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 Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

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 Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

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

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

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

Clinical Study Report AI Final 28 Feb Volume: Page:

Clinical Study Report AI Final 28 Feb Volume: Page: Study Design, Continued Electrocardiogram (ECG) and vital sign assessments were done at select times during the study. Blood and urine samples for clinical laboratory evaluations were collected at specified

More information

Study No. 178-CL-008 Report Final Version, 14 Dec 2006 Reissued Version, 18 Jul 2011 Astellas Pharma Europe B.V. Page 13 of 122

Study No. 178-CL-008 Report Final Version, 14 Dec 2006 Reissued Version, 18 Jul 2011 Astellas Pharma Europe B.V. Page 13 of 122 Page 13 of 122 3 SYNOPSIS Title of study: (International) Study No: A randomized, double-blind, parallel group, proof-of-concept study of in comparison with placebo and tolterodine in patients with symptomatic

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

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

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

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

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

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

Clinical Trial Results Summary Study EN

Clinical Trial Results Summary Study EN Study Number: EN3288-113 Title of Study: A Double-blind, Dose-Ranging, Pilot Study to Evaluate the Safety, Subjective Effects, and Pharmacokinetics of Oxymorphone Hydrochloride in Healthy Subjects Who

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

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

2.0 Synopsis. ABT-333 M Clinical Study Report R&D/09/956

2.0 Synopsis. ABT-333 M Clinical Study Report R&D/09/956 2.0 Synopsis Abbott Laboratories Individual Study Table Referring to Part of Dossier: (For National Authority Use Only) Name of Study Drug: ABT-333 Volume: Name of Active Ingredient: Page: Sodium N-{6-[3-tert-butyl-5-(2,4-

More information

Title of Study: Evaluation of Efficacy and Safety of Galantamine in Patients With Dementia of Alzheimer's Type Who Failed to Benefit From Donepezil

Title of Study: Evaluation of Efficacy and Safety of Galantamine in Patients With Dementia of Alzheimer's Type Who Failed to Benefit From Donepezil SYNOPSIS Name of Sponsor/Company Name of Finished Product REMINYL Name of Active Ingredient(s) Galantamine hydrobromide Issue Date: 18 October 2013 Protocol No.: Title of Study: Evaluation of Efficacy

More information

Poster O_16. Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA; 2. Lifetree Clinical Research, Salt Lake City, UT, USA

Poster O_16. Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA; 2. Lifetree Clinical Research, Salt Lake City, UT, USA Poster O_16 Lack of PK Interaction Between the HCV Protease Inhibitor MK-5172 and Methadone and Buprenorphine/Naloxone in Subjects on Stable Opiate Maintenance Therapy Iain Fraser, 1 Wendy W. Yeh, 1 Christina

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

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

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

Principal Investigator. Study center(s) This was a single-center study. Publications None at the time of writing this report.

Principal Investigator. Study center(s) This was a single-center study. Publications None at the time of writing this report. (For national authority SYNOPSIS use only) Date 3 March 2005 An open, randomized, two-way crossover study evaluating the pharmacokinetics of budesonide and formoterol from Symbicort pmdi versus Oxis Turbuhaler

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

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before

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

Effect of Multiple-Dose Ketoconazole and the Effect of Multiple-Dose Rifampin on Pharmacokinetics (PK) of the HCV NS3 Protease Inhibitor Asunaprevir

Effect of Multiple-Dose Ketoconazole and the Effect of Multiple-Dose Rifampin on Pharmacokinetics (PK) of the HCV NS3 Protease Inhibitor Asunaprevir Effect of Multiple-Dose Ketoconazole and the Effect of Multiple-Dose Rifampin on Pharmacokinetics (PK) of the HCV NS3 Protease Inhibitor Asunaprevir Eley T, 1 He B, 1 Huang S-P, 2 Stonier M, 1 Bedford

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

Mipomersen (ISIS ) Page 2 of 1979 Clinical Study Report ISIS CS3

Mipomersen (ISIS ) Page 2 of 1979 Clinical Study Report ISIS CS3 (ISIS 301012) Page 2 of 1979 2 SYNOPSIS ISIS 301012-CS3 synopsis Page 1 Title of Study: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics,

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

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

SYNOPSIS. ER OROS Paliperidone: Clinical Study Report R SCH-301

SYNOPSIS. ER OROS Paliperidone: Clinical Study Report R SCH-301 SYNOPSIS Protocol No.: R076477-SCH-301 Title of Study: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With an Open-Label Extension Evaluating Extended Release OROS Paliperidone in

More information

Merck Sharp & Dohme Corp., The Netherlands; Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA; Yale University, New Haven, CT, USA;

Merck Sharp & Dohme Corp., The Netherlands; Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA; Yale University, New Haven, CT, USA; Pharmacokinetic Interaction Between HCV Protease Inhibitor Boceprevir and Methadone or Buprenorphine/Naloxone in Subjects on Stable Maintenance Therapy Ellen GJ Hulskotte, 1 Hwa-Ping Feng, 2 R Douglas

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

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

2. SYNOPSIS Name of Sponsor/Company:

2. SYNOPSIS Name of Sponsor/Company: in patients with refractory partial seizures 14 Jun 2007 2. SYNOPSIS TITLE OF STUDY: Efficacy and safety of BIA 2-093 as adjunctive therapy for refractory partial seizures in a double-blind, randomized,

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

Journal of Global Trends in Pharmaceutical Sciences

Journal of Global Trends in Pharmaceutical Sciences An Elsevier Indexed Journal ISSN-2230-7346 Journal of Global Trends in Pharmaceutical Sciences ARTICLE INFO PHARMACOKINETICS, SAFETY AND TOLERABILITY OF EMPAGLIFLOZIN/METFORMIN FIXED-DOSE COMBINATION VS

More information