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CTRI Number  CTRI/2013/08/003913 [Registered on: 23/08/2013] Trial Registered Retrospectively
Last Modified On: 16/08/2013
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Bioequivalence study of Diclofenac Sodium150 mg Sustained Release Tablets 
Scientific Title of Study   Bioequivalence study of Letzmove TM IR/ER tablets, each sustained release tablet containing 150 mg Diclofenac Sodium manufactured by Novartis India Limited compared with Arthrofast tablets, each modified release tablet containing 150 mg Diclofenac Sodium marketed by Novartis Pharma Egypt. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
DI130111-01, version no. 01, dated 11th Jan 2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prashant Kulkarni 
Designation  Principal Investigator 
Affiliation  THERAPEUTIC DRUG MONITORING LABORATORY 
Address  THERAPEUTIC DRUG MONITORING LABORATORY 194 Scheme No 6 Road No 15 Sion Koliwada Sion (E) Mumbai 400 022 India

Mumbai
MAHARASHTRA
400022
India 
Phone    
Fax    
Email  prashantkulkarniin@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Atul Sharma 
Designation  Medical Advisor 
Affiliation  Novartis India Limited 
Address  Novartis India Limited Shiv Sagar Estate Dr.ABRoad Worli

Mumbai
MAHARASHTRA
400018
India 
Phone    
Fax    
Email  atul-2.sharma@novartis.com  
 
Details of Contact Person
Public Query  
Name  Dr Atul Sharma 
Designation  Medical Advisor 
Affiliation  Novartis India Limited 
Address  Novartis India Limited Shiv Sagar Estate Dr.ABRoad Worli


MAHARASHTRA
400018
India 
Phone    
Fax    
Email  atul-2.sharma@novartis.com  
 
Source of Monetary or Material Support  
Novartis India Limited 
 
Primary Sponsor  
Name  Novartis India Limited 
Address  Shiv Sagar Estate Dr AB Road Worli 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prashant Kulkarni  Therapeutic Drug Monitoring Laboratory   Therapeutic Drug Monitoring Laboratory 194, Scheme No. 6, Road No. 15 Sion- Koliwada, Sion (East) Mumbai – 400 022, Maharashtra – India.
Mumbai
MAHARASHTRA 		 91-22-24078300

prashantkulkarniin@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
TDML Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  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. 
 
Intervention / Comparator Agent  
Type  Name  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 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 Name 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.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  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 India’s table for ideal height and weight. BMI should fit as per Life Insurance Corporation’s of India’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 study after they duly sign the Informed Consent Form. Volunteer who does not meet the above mentioned criteria shall be excluded from the study.
 
 
ExclusionCriteria 
Details  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   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate bioavailability of single dose of Letzmove TM IR/ER tablets, each sustained release tablet containing 150 mg Diclofenac Sodium manufactured by Novartis India Limited compared with Arthrofast tablets, each modified release tablet containing 150 mg Diclofenac 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 release tablet containing 150 mg Diclofenac Sodium manufactured by Novartis India Limited compared with Arthrofast tablets, each modified release tablet containing 150 mg Diclofenac Sodium marketed by Novartis Pharma Egypt., using a randomized two way crossover design under fed condition.
 		 13 days 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/06/2013 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="13" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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.

 
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