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CTRI Number  CTRI/2021/06/034239 [Registered on: 15/06/2021] 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 fixed dose combination of gliclazide XR 60 mg plus Metformin XR1000 mg under fasting condition 
Scientific Title of Study   An open-label, balanced, randomized, two treatment, two sequence, two period, two way cross-over, single oral dose bioequivalence study Gliclazide 60 mg and metformin hydrochloride 1000 mg extended release tablets of Serdia Pharmaceuticals (India), Pvt. Ltd., with Reclimet XR Forte Tablets (Gliclazide and metformin extended release tablets 60mg plus1000 mg) of Dr Reddy’s Laboratories Ltd, India in healthy, adult, male human subjects under fasting conditions.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CT-07-39/2021 DATED 25TH MAY 2021  DCGI 
Protocol No.: PR/BE/20/400 Version No.: 01 30/4/2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yashvant Khaire 
Designation  Clinical Investigator 
Affiliation  Raptim Research Pvt. Ltd 
Address  Unit A 226 TTC Industrial Area Mahape MIDC Navi Mumbai
Unit A 226 TTC Industrial Area Mahape MIDC Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400710
India 
Phone  02227781889  
Fax  02227781884  
Email  yashvant.khaire@raptimresearch.com  
 
Details of Contact Person
Scientific Query  
Name  Sofi Joseph 
Designation  Head RA and Pharmacovigilance 
Affiliation  Serdia Pharmaceuticals (India) Pvt. ltd 
Address  1703 17th Floor Parinee Crescenzo B Wing Plot noC 38 39, G‖ Block Behind MCA Bandra Kurla Complex Bandra East Mumbai
1703 17th Floor Parinee Crescenzo B Wing Plot noC 38 39, G‖ Block Behind MCA Bandra Kurla Complex Bandra East Mumbai Mumbai
Mumbai (Suburban)
MAHARASHTRA
400051
India 
Phone  02268100700  
Fax  02268100700  
Email  sofi.joseph@servier.com  
 
Details of Contact Person
Public Query  
Name  Sofi Joseph 
Designation  Head RA and Pharmacovigilance 
Affiliation  Serdia Pharmaceuticals (India) Pvt. ltd 
Address  1703 17th Floor Parinee Crescenzo B Wing Plot noC 38 39, G‖ Block Behind MCA Bandra Kurla Complex Bandra East Mumbai
1703 17th Floor Parinee Crescenzo B Wing Plot noC 38 39, G‖ Block Behind MCA Bandra Kurla Complex Bandra East Mumbai Mumbai

MAHARASHTRA
400051
India 
Phone  02268100700  
Fax  02268100700  
Email  sofi.joseph@servier.com  
 
Source of Monetary or Material Support  
Serdia Pharmaceuticals (India) Pvt.ltd. Mumbai  
 
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 Bandra Kurla Complex 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  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yashvant Khaire  Raptim Research Pvt Ltd  Screening Facility PAP213 Clinical Pharmacology Unit A 226 Bioanalytical and Biostatistical Unit A 242 TTC Industrial Area Mahape MIDC Navi Mumbai 400 710
Mumbai (Suburban)
MAHARASHTRA 		 02227781889
02227781884
yashvant.khaire@raptimresearch.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HumanCare Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy adult male human subjects 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Reference product   Reclimet XR Forte Tablets (Gliclazide and metformin extended release tablets 60mg plus 1000 mg) of Dr Reddy‘s Laboratories Ltd, India. one single tablet oral dose  
Intervention  Test Product   Gliclazide 60 mg and metformin hydrochloride 1000 mg extended release tablets one single tablet oral dose  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  Willing to be available for the entire study period and to comply protocol
requirements;
Healthy, adult, human subject of 18-45 years (both inclusive) of age;
Body mass index in the range of 18.50 – 30.00 kg/m2 (both inclusive);
Normal health status as determined by baseline medical and medication history, at
the time of screening and vital signs measurements and clinical examination at the
time of screening as well as check-in of each study period;
Normal or clinically non-significant laboratory values as determined by
hematological, biochemistry tests and urine analysis;
Normal or clinically non-significant 12-lead ECG recording
Non-smokers or mild/moderate smokers with not more than 10 bidis/cigarettes/pipes
per day, and willing to abstain from smoking or chewing any tobacco containing
products at least 72.00 hours prior to check-in until last sample collection in each
study period;
Willing to abstain from alcohol or alcoholic products at least 24.00 hours prior to
check-in until last sample collection in each study period;
Willing to abstain from xanthine or its derivative containing food or beverages (e.g.
chocolates, tea, coffee or cola drinks), at least 48.00 hours prior to check-in until last
sample collection in each study period;
Willing to abstain from grapefruit or its juice at least 72.00 hours prior to check-in
until last sample collection in each study period;

 
 
ExclusionCriteria 
Details  Use of any prescribed medication (including herbal medicines and vitamin
supplements) or OTC products within 30 days prior to first check-in and throughout
the study;
History or presence of significant gastric and/or duodenal ulceration;
Difficulty in swallowing tablets or capsules;
Use of any recreational drug or history of drug addiction;
Participated in any clinical investigation requiring repeated blood sampling or have
donated blood in past 90 days prior to first check-in;
Positive urine alcohol or urine drug of abuse tests during check-in of each study
period;
Positive test for Human Immunodeficiency Virus (HIV) type I/II antibodies,
Hepatitis B surface antigen (HBsAg) and Hepatitis C virus antibodies;
History of allergy or hypersensitivity intolerance to Gliclazide and Metformin or its
formulation excipients which, in the opinion of a clinical investigator, would
compromise the safety of the subject or the study;
History of difficulty in accessibility of veins in arms.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess bioequivalence of the test product in comparison
with the reference product
 		 Blood samples will be drawn at
0.00 (within 2.00 hours prior to dosing), 1.00, 2.00, 3.00, 4.00, 5.00, 6.00,
7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 13.00, 14.00, 16.00, 20.00, 24.00,
36.00, 48.00, 72.00 and 96.00 hours post-dose
 
 
Secondary Outcome  
Outcome  TimePoints 
To assess safety and tolerability of the test product in
comparison with the reference product.

 		 -24.00 (±45
minutes of scheduled time), 0.00 (within 2.00 hours) hours prior to dosing
and at 3.00, 6.00 and 11.00 hours post-dose (±45 minutes of scheduled time) 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
Final Enrollment numbers achieved (Total)= "49"
Final Enrollment numbers achieved (India)="49" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   15/06/2021 
Date of Study Completion (India) 08/07/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not applicable  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Serdia Pharmaceuticals (India) Pvt. Ltd. has developed a fixed dose combination tablet containing gliclazide 60 mg with metformin 1000 mg ( both extended release) as a bi-layered tablet. Similar product is approved in India manufactured and marketed by Dr. Reddy’s Laboratories Ltd., India.

This proposed project is an open-label, balanced, randomized, two treatment, two sequence, two period, two way cross-over, single oral dose bioequivalence study Gliclazide 60 mg and metformin hydrochloride 1000 mg extended release tablets of Serdia Pharmaceuticals (India), Pvt. Ltd., with Reclimet XR Forte Tablets (Gliclazide and metformin extended release tablets 60mg+1000 mg) of Dr Reddy’s Laboratories Ltd, India in healthy, adult, male human subjects under fasting conditions.
 
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