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CTRI Number  CTRI/2023/02/049975 [Registered on: 22/02/2023] Trial Registered Prospectively
Last Modified On: 07/03/2023
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Bioequivalence study of Gliclid 60 mg MR tablet in healthy human subjects. 
Scientific Title of Study   An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Gliclid 60 mg MR tablet (Gliclazide 60 mg MR tablet) of The ACME Laboratories Ltd., in comparison with Diamicron 60 mg MR tablet (Gliclazide 60 mg MR tablet) of Les Laboratories Servier Industrie in healthy, adult, human subjects under fasting condition. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ICBio/019/0522, Version: 00, Date: 19 May 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priya R 
Designation  Principal Investigator 
Affiliation  ICBio Clinical Research Pvt Ltd 
Address  16and18 ICBio Tower Yelahanka Main Road Chikkabetahalli Vidyaranyapura

Bangalore
KARNATAKA
560097
India 
Phone  9900111997  
Fax    
Email  pi.mail@icbiocro.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harish S 
Designation  Director Operation 
Affiliation  ICBio Clinical Research Pvt Ltd 
Address  16and18 ICBio Tower Yelahanka Main Road Chikkabetahalli Vidyaranyapura

Bangalore
KARNATAKA
560097
India 
Phone  9900111997  
Fax    
Email  harish@icbiocro.com  
 
Details of Contact Person
Public Query  
Name  Dr Harish S 
Designation  Director Operation 
Affiliation  ICBio Clinical Research Pvt Ltd 
Address  16and18 ICBio Tower Yelahanka Main Road Chikkabetahalli Vidyaranyapura

Bangalore
KARNATAKA
560097
India 
Phone  9900111997  
Fax    
Email  harish@icbiocro.com  
 
Source of Monetary or Material Support  
The ACME Laboratories Ltd Court de la ACME 1/4, Kallayanpur Mirpur road Dhaka- 1207 Bangladesh  
 
Primary Sponsor  
Name  The ACME Laboratories Ltd 
Address  Court de la ACME 1/4, Kallayanpur Mirpur road Dhaka- 1207 Bangladesh 
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 Harish S  ICBio Clinical Research Pvt Ltd  16and18 ICBio Tower Yelahanka Main Road Chikkabetahalli Vidyaranyapura
Bangalore
KARNATAKA 		 9900111997

harish@icbiocro.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy subjects 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Diamicron 60 mg MR tablet (Gliclazide 60 mg MR tablet) Name of the drug: Gliclazide   bioequivalence study, dose: 60 mg, frequency: single dose, route of administration: oral, duration of the study: 14 days. 
Intervention  Gliclid 60 mg MR tablet (Gliclazide 60 mg MR tablet) Name of the drug: Gliclazide  bioequivalence study, dose: 60 mg, frequency: single dose, route of administration: oral, duration of the study: 14 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1 Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study
2 Willing to be available for the entire study period and to comply with protocol requirements.
3 Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age.
4 Body mass index in the range of 18 – 30 kg/m2 (both inclusive).  
 
ExclusionCriteria 
Details  • Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or blood–forming organs.
• History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
• History of severe infection or major surgery in the past 6 months.
• History of Minor surgery or fracture within the past 3 months. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Cmax, AUC0-t and AUC0-∞  Day 01- Day 14 
 
Secondary Outcome  
Outcome  TimePoints 
Tmax , AUC_%Extrap_obs, λz and t1/2  Day 01- Day 14 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/02/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="14" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Gliclid 60 mg MR tablet (Gliclazide 60 mg MR tablet) of The ACME Laboratories Ltd., in comparison with Diamicronâ 60 mg MR tablet (Gliclazide 60 mg MR tablet) of Les Laboratories Servier Industrie in healthy, adult, human subjects under fasting condition.

Primary objective:

To compare the rate and extent of absorption of Gliclid 60 mg MR tablet (Gliclazide 60 mg MR tablet) of The ACME Laboratories Ltd., with that of Diamicronâ 60 mg MR tablet (Gliclazide 60 mg MR tablet) of Les Laboratories Servier Industrie in healthy, adult, human subjects under fasting condition.

Secondary objective:

To monitor the safety and tolerability of the study subjects after administration of Gliclazide 60 mg MR tablets in healthy, adult, human subjects under fasting condition.

Number of subjects: Twenty eight (28)
 
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