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CTRI Number  CTRI/2020/02/023327 [Registered on: 14/02/2020] Trial Registered Prospectively
Last Modified On: 17/08/2023
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Bioequivalence study of Trimetazidine Dihydrochloride Extended Release Capsules 80 mg under fasting conditions. 
Scientific Title of Study   An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of trimetazidine dihydrochloride extended release capsules 80 mg (Trade Name FLAVEDON OD) OF SERDIA PHARMACEUTICALS PVT. LTD., INDIA comparing with Vastarel® OD 80 MG prolonged release hard capsule (TRADE NAME VASTAREL® OD 80 MG) OF EGIS PHARMACEUTICALS PLC, Hungary, in normal, healthy, adult, human male subjects under fasting condition. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
PROJECT NO. 0324-19 Version 1.0,26-Jul-2019  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shrikrishna Kolte MD 
Designation  Principal Investigator 
Affiliation  Lambda Therapeutic Research Ltd.  
Address  Clinical Pharmacology and Medical Affairs Lambda House, Plot no. 38, Survey No. 388, Near. Silver Oak Club, Off. S. G. Highway, Gota,

Ahmadabad
GUJARAT
382481
India 
Phone  7940202020  
Fax  7940202021  
Email  shrikrishnaskolte@lambda-cro.com  
 
Details of Contact Person
Scientific Query  
Name  Sofi Joseph 
Designation  Head of Regulatory Affairs And Pharmacovigilance 
Affiliation  Serdia Pharmaceuticals (INDIA) Pvt.Ltd. 
Address  Regulatory Affairs Department, 1703, 17th floor, Parinee Crescenzo, B-wing, Plot No- C 38/39, G-Block, Behind MCA, BKC, Bandra east

Mumbai
MAHARASHTRA
400051
India 
Phone  02268100760  
Fax    
Email  sofi.joseph@servier.com  
 
Details of Contact Person
Public Query  
Name  Sofi Joseph 
Designation  Head of Regulatory Affairs And Pharmacovigilance 
Affiliation  Serdia Pharmaceuticals (INDIA) Pvt.Ltd. 
Address  Regulatory Affairs department 1703, 17th floor, Parinee Crescenzo, B-wing, Plot No- C 38/39, G-Block, Behind MCA, BKC, Bandra east

Mumbai
MAHARASHTRA
400051
India 
Phone  02268100760  
Fax    
Email  sofi.joseph@servier.com  
 
Source of Monetary or Material Support  
Serdia Pharmaceuticals (India) Pvt. Ltd 
 
Primary Sponsor  
Name  Serdia Pharmaceuticals India Pvt Ltd 
Address  1703, 17th floor, Parinee Crescenzo, B-wing, Plot No- C 38/39, G-Block, Behind MCA, BKC, Bandra east, Mumbai-400051 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shrikrishna Kolte MD  Lambda Therapeutic Research Ltd.   Clinical Pharmacology and Medical Affairs Lambda House, Plot no. 38, Survey No. 388, Near. Silver Oak Club, Off. S. G. Highway, Gota,Ahmadabad GUJARAT-382481
Ahmadabad
GUJARAT 		 07940202267

shrikrishnaskolte@lambda-cro.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Anveshhan Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Fasting conditions 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Trimetazidine Dihydrochloride Extended Release Capsules 80 mg (Trade name FLAVEDON OD)  Single Dose cross over study. Trimetazidine is indicated in adults as an add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies. 
Comparator Agent  VASTAREL® OD 80 mg Prolonged Release Hard Capsule (Trade name VASTAREL® OD 80 mg)  Single Dose cross over study. Each prolonged release hard capsule contains 80 mg of Trimetazidine 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1. Non-smokers, normal, healthy, adult, human male volunteers between 18 to 45 years of age (both inclusive).
2. Having a Body Mass Index (BMI) ranging within18.5 to 30.0 (both inclusive), calculated as weight in kg / height in m2.
3. Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and X-ray chest (P/A view) recordings.
4. Able to understand and comply with the study procedures, in the opinion of the investigator.
5. Able to give voluntary written informed consent for participation in the study.

 
 
ExclusionCriteria 
Details  1. Known hypersensitivity to Trimetazidine or any excipients or any related drug or any substance.
2. History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
3. Ingestion of a medication (prescribed & over the counter (OTC) medication including herbal remedies) at any time within 14 days prior to check-in in period-I. In any such case subject selection will be at the discretion of the Principal Investigator / designee.
4. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
5. Subject having CrCL ≤ 60 ml/min at screening.
6. A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40 % distilled spirits, such as rum, whisky, brandy etc.) or consumption of alcohol or alcoholic products within 48 hours prior to check-in of period-I.
7. Smokers or who have smoked within last 06 months prior to start of the study.
8. The presence of clinically significant abnormal laboratory values during screening.
9. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
10. A history of difficulty with donating blood.
11. Difficulty in swallowing solid dosage forms like tablets or capsules.
12. Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
13. Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication (If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received)
14. A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
15. A positive test result for HIV antibody (I & II).
16. Consumption of grape fruit or grape fruit products within 72 hours prior to check-in of period-I.
17. An unusual diet, for whatever reason (for example, fasting, high potassium or low-sodium), for four weeks prior to check-in in period-I. In any such case subject selection will be at the discretion of the Principal Investigator.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor’s test product [Trimetazidine Dihydrochloride Extended Release Capsules 80 mg (Trade name FLAVEDON OD)] relative to that of reference product [VASTAREL® OD 80 mg Prolonged Release Hard Capsule (Trade name VASTAREL® OD 80 mg)] after single oral dose administration in normal, healthy, adult, human male subjects under fasting condition and to demonstrate the bio-equivalence between both treatments.  Day 1: Day of dosing.
Day 2, 3, 4: Subsequent days after dosing. 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety of the subjects  Day 4 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "21"
Final Enrollment numbers achieved (India)="21" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/02/2020 
Date of Study Completion (India) 27/02/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="20" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor’s test product [Trimetazidine Dihydrochloride Extended Release Capsules 80 mg (Trade name FLAVEDON OD)] relative to that of reference product [VASTAREL® OD 80 mg Prolonged Release Hard Capsule (Trade name VASTAREL® OD 80 mg)] after single oral dose administration in normal, healthy, adult, human male subjects under fasting condition and to demonstrate the bioequivalence between both treatments. 
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