Clinical Trial Details (PDF Generation Date :- Wed, 17 Apr 2019 02:24:18 GMT) CTRI Number Last Modified On 16/08/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2013/08/003913 [Registered on: 23/08/2013] - Trial Registered Retrospectively No BA/BE Randomized, Crossover Trial Bioequivalence study of Diclofenac Sodium150 mg Sustained Release Tablets Bioequivalence study of Letzmove TM IR/ER tablets, each sustained release tablet containing 150 mg Diclofenac Sodium manufactured by Novartis Limited compared with Arthrofast tablets, each modified Sodium marketed by Novartis Pharma Egypt. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) DI130111-01, version no. 01, dated 11th Jan 2013 Protocol Number Details of Principal Investigator Dr Prashant Kulkarni Principal Investigator THERAPEUTIC DRUG MONITORING LABORATORY THERAPEUTIC DRUG MONITORING LABORATORY 194 Scheme No 6 Road No 15 Sion Koliwada Sion (E) 400 022 400022 prashantkulkarniin@yahoo.co.in Details Contact Person (Scientific Query) Dr Atul Sharma Medical Advisor Novartis Limited Novartis Limited Shiv Sagar Estate Dr.ABRoad Worli 400018 atul-2.sharma@novartis.com Details Contact Person (Public Query) Dr Atul Sharma Medical Advisor Novartis Limited Novartis Limited Shiv Sagar Estate Dr.ABRoad Worli 400018 page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent > Novartis Limited Type of Sponsor NIL List of Countries of Principal Investigator Dr Prashant Kulkarni atul-2.sharma@novartis.com Source of Monetary or Material Support Primary Sponsor Details Novartis Limited Shiv Sagar Estate Dr AB Road Worli Pharmaceutical industry-global NIL of Site Site // Therapeutic Drug Monitoring Laboratory Therapeutic Drug Monitoring Laboratory 194, Scheme No. 6, Road No. 15 Sion- Koliwada, Sion (East) 400 022, Maharashtra. 91-22-24078300 prashantkulkarniin@ya hoo.co.in of Committee Approval Status Date of Approval Is Independent Ethics Committee? TDML Ethics Committee Status Approved 23/01/2013 No Date Approved/Obtained 28/01/2013 Health Type Healthy Human Volunteers Condition Since this is a BA/BE study, the trial participants are healthy volunteers and the study drug is being given to them. So there is no condition as such which is being studied. Type Details Intervention Diclofenac Sodium 150 mg Sustained Release Tablets Diclofenac, as the sodium salt, is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. Diclofenac, as the sodium salt, is a faintly yellowish white to light beige, virtually odorless, slightly hygroscopic crystalline powder. The recommended dose of Diclofenac is 50-150 mg once a day with or without food.diclofenac Sodium is administered by Oral route at page 2 / 5
Inclusion Criteria dose of 50 to 150 mg/day. Total expected duration of the study will be of at least 13 days from the day of check in of the first period till the end of second period. Comparator Agent Diclofenac Sodium Brand Arthrofast Manufactured at Minapharma Egypt for Novartis Pharma Egypt. The recommended dose of Diclofenac is 50-150 mg once a day with or without food.diclofenac Sodium is administered by Oral route at dose of 50 to 150 mg/day. Total expected duration of the study will be of at least 13 days from the day of check in of the first period till the end of second period. Age From Age To Gender Details 18.00 Year(s) 45.00 Year(s) Male Inclusion Criteria The volunteers will be screened as per Case report form Age & Sex : Adult, Male Between 18 45 years Height & Weight : Between ±15% as per Life Insurance Corporation s of s table for ideal height and weight. BMI should fit as per Life Insurance Corporation s of s table for ideal height and weight, preferably between 18-25 kg/m2 Smoking : Non smoker Physical Examination : No evidence of underlying disease. Clinical Examination : No evidence of medical disorders or impairments (Hepatic, renal, cardiac, GIT and psychiatric). No vital sign abnormalities (BP, Pulse etc.) Laboratory Findings : No clinically significant abnormal laboratory values during the pre-study screening. Values for Clinical Biochemistry, Hematology, Liver and Kidneys function tests and Urinalysis in acceptable limits. HIV, Hepatitis B : Negative in screening or non-reactive Cardiac Function : Acceptable ECG Contraindication / Allergy : No history of contraindication and / or allergy to the drug or any related compounds Concurrent / Systemic medication : No consumption of drugs for two weeks prior to the study Drug / Alcohol Abuse : No drug consumed at least 14 days prior to first study drug administration or alcohol at least 48 hours prior to first study drug administration. Participation in Bio-study : Should not have been participated in any Bioavailability or Bioequivalence studies at least 90 days prior to this present study. Volunteer Cooperation : Agrees to abide by the diet and fluid restrictions as required by the study. Agrees to abstain from xanthine containing foods, tobacco and alcohol from at-least 48 hours prior to first drug administration until the follow up examination. Volunteer availability : Agrees to be confined to study center during the study period. Is available for entire study duration for blood sampling or otherwise. Volunteers meeting all the above criteria shall be included in the page 3 / 5
study after they duly sign the Informed Consent Form. Volunteer who does not meet the above mentioned criteria shall be excluded from the study. Exclusion Criteria Details Exclusion Criteria The volunteers will be excluded based on the following criteria: History of hypersensitivity to the study drug or related products. Significant history or presence of psychiatric, gastrointestinal, liver or kidney disorder/impairments, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications. Significant history of asthma, chronic bronchitis or other bronchospastic condition. Significant history or presence of glaucoma, cardiovascular or hematological disease or diabetes or metabolic acidosis or with a known food allergy. Significant history or presence of smoking. Any clinically significant illness during the 4 weeks prior to day one of this study or hospitalized during 3 months prior to the commencement of this study. Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease. Participation in a clinical trial with an investigation drug within 90 days preceding day 1 of the current study. Use of enzyme-modifying drugs within 30 days prior to day 1 of this study. Use of any systemic medication (including OTC preparations) within 14 days proceeding day 1 of this study. Had a depot injection or an implant of any drug 3 months prior to the commencement of this study. Donated blood (350ml) within 3 months prior to the commencement of this study. HIV and hepatitis positive findings. Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Pre-numbered or coded identical Containers Not Applicable Primary Outcome Outcome Timepoints To estimate bioavailability of single dose of Letzmove TM IR/ER tablets, each sustained Sodium manufactured by Novartis Limited compared with Arthrofast tablets, each modified Sodium marketed by Novartis Pharma Egypt., using a randomized two way crossover design under fed condition. 13 days Secondary Outcome Outcome Timepoints To estimate bioavailability of single dose of Letzmove TM IR/ER tablets, each sustained Sodium manufactured by Novartis Limited compared with Arthrofast tablets, each modified Sodium marketed by Novartis Pharma Egypt., 13 days page 4 / 5
Powered by TCPDF (www.tcpdf.org) using a randomized two way crossover design under fed condition. Target Sample Size Phase of Trial Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Total Sample Size=26 Sample Size from =26 N/A 10/06/2013 No Date Specified Years=0 Months=0 Days=13 Not Applicable Completed Brief Summary This is a bioequivalence study on Diclofenac Sodium150 mg sustained release tablets. The study will be conducted as a two way, two sequence, randomized, crossover study on twenty four + 2 (stand-by) healthy male human volunteers. The information on the drug, the clinical procedures, the bio-analytical method and requisite regulatory documentation procedures to be followed has been documented. page 5 / 5