Bioequivalence study of Gliclazide 30 mg Extended Release Tablet (Tehran Chemie) versus Diamicron MR (SERVIER) Tablet after single oral dosing in healthy volunteers
Bioequivalence study of Gliclazide 30 mg Extended Release Tablet (Tehran Chemie) versus Diamicron MR (SERVIER) Tablet after single oral dosing in healthy volunteers
Design
Bioequivalence study, with control group, double-blind, randomized, on 24 volunteers, from each volunteer 20 blood samples were taken. Sealed envelope is used for randomization.
Settings and conduct
The subject of this biopharmaceutical and pharmacokinetic study is the location of Blood collection center of Tam Pouya Company located in Tehran. The study was blinded to the study participants by removing the drugs from the original package and placing the test and reference drugs in the same package, and the participants were not aware of the type of drug they were taking.The crossover design is such that the Iranian drug will be prescribed to the first group in the first week and to the second group in the second week. Brand medicine, on the contrary, Iranian medicine will be prescribed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: general health (liver, heart and kidneys); body mass index (18-28); informed consent; age (50-18). Exclusion criteria: smoking; history of cardiovascular disease; history of liver disease and Renal; alcohol and drug addiction; history of allergy to Gliclazide.
Intervention groups
Intervention group: Receives one tablet of test drug (Gliclazide 30 mg Tablet Tehran Chemie). Control group: Receives one reference medicine Tablet (Diamicron 60 mg SERVIER Pharmaceutical Company).
Main outcome variables
Determination of blood concentration profile parity of brand drug with generics
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220111053692N10
Registration date:2023-04-16, 1402/01/27
Registration timing:registered_while_recruiting
Last update:2023-04-16, 1402/01/27
Update count:0
Registration date
2023-04-16, 1402/01/27
Registrant information
Name
Bardia Jamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 4707
Email address
info@tampouya.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-15, 1401/01/26
Expected recruitment end date
2023-04-20, 1402/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of Gliclazide 30 mg Extended Release Tablet (Tehran Chemie) versus Diamicron MR (SERVIER) Tablet after single oral dosing in healthy volunteers
Public title
Bioequivalence study of Gliclazide 30 mg Extended Release Tablet (Tehran Chemie) versus Diamicron MR (SERVIER) Tablet after single oral dosing in healthy volunteers
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 55 years old
Weight in range of 10 % proper body weight
All volunteers should be in a good health condition on the basis of medical history ,physical examination , routine blood test.
Possessing negative test for hepatitis B surface antigen (HBs-Ag), Antihepatitis-C antibody (anti-HCV) and anti-HIV.
Gender: male
Exclusion criteria:
Volunteers with hypersensitivity to Gliclazide were excluded.
Those with known history of drug abuse. alcohol consumer or cigarette smokers.
Taking medications that have drug interactions with gliclazide until one month before studying.
Disinclination to take the test
Blood donation or blood loss of more than 200 ml in the past month
Age
From 18 years old to 55 years old
Gender
Male
Phase
Bioequivalence
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly allocate people in two groups, 24 cards with numbers 1 to 24 will be used in closed envelopes that are placed in random order. After entering the study, each candidate will take an envelope, numbers 1-12 will be in group A and numbers 13-24 will be in group B. Group A will receive intervention 1 (test product) and group B will receive intervention 2 (reference product) and after the first period, the interventions of the two groups will be moved for the second period
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a Double-blind (participant) clinical trial. Gliclazide and Diamicron tablets are removed from the package by the administrator and placed in similar and coded cans.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees of The Institute of Pharmaceutical Sciences,Tehran University of Medical Sciences
Street address
Research Institute of Pharmaceutical Sciences, second floor of the old building, Faculty of Pharmacy, Enqelab Square, 16 Azar St.
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2023-04-09, 1402/01/20
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.005
Health conditions studied
1
Description of health condition studied
Bioequivalence study of Gliclazide 30 mg Extended Release Tablet (Tehran Chemie) versus Diamicron MR (SERVIER) Tablet after single oral dosing in healthy volunteers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Drug concentration in plasma samples
Timepoint
In times 0 ، 0/5، 1، 2 ،3، 4، 5، 6، 6/5 ، 7، 7/5 ، 8 ، 8/5 ، 9 ، 9/5 ، 10 ، 11 ، 24 ، 32 ، 48 Hours after the start of the intervention
Method of measurement
chromatography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receives one tablet of test drug (Gliclazide 30 mg tablet pharmaceutical company Tehran Chemie). Blood samples were taken from the volunteers for 48 hours at the mentioned times after drug administration and the drug concentration in plasma samples was measured by liquid chromatography with UV detector.