Clinical Bioequivalence Study on Two Gliclazide 80mg Tablet Formulations

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Diamicron 80mg Tablet; Drug: BF-Gliclazide Tablet 80mg

• Registration Number: NCT02643329
• Lead Sponsor: Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited

Brief Summary

The purpose of the study is to compare the bioavailability of a generic product of gliclazide (Product Name: BF-Gliclazide Tablet 80mg, Manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited) with that of reference product (Product Name: Diamicron 80mg Tablet, Manufactured by Les Laboratoires Servier Industrie, France) when administered to healthy volunteers under fasting conditions. The plasma pharmacokinetic data of gliclazide obtained from two formulations will be used to access the interchangeability of the products.

Detailed Description

The study design is a single-dose, two-treatment, two-period, two-sequence crossover with a washout period of one to two weeks. During each study session, healthy male subjects will be administered a single oral dose of 80 mg gliclazide (one BF-Gliclazide Tablet 80 mg or one Diamicron 80 mg Tablet) after an overnight fast of approximately 10 hours. 20% glucose will be given orally to each subject at 2 h after drug administration to minimize the risk of hypoglycaemia. Venous blood samples will be collected at pre-dose (0 h) and up to 72 hours post-dose. The plasma concentrations of gliclazide will be determined by a validated assay. The non-compartmental method will be used to analyze the plasma concentration-time data and calculate the main pharmacokinetic parameters such as Cmax, Tmax, AUC0-last, AUC0-inf and T1/2. ANOVA will be conducted on logarithmically transformed Cmax, AUC0-last and AUC0-inf. The two one-sided tests will be used to calculate the 90% confidence intervals for the mean difference in AUC0-last, AUC0-inf and Cmax, and to assess the bioequivalence of the two products.

Study Timeline

• Study First Submitted: 2015-12-28
• Study First Submitted QC: 2015-12-29
• Study First Posted: 2015-12-31
• Study Start: 2016-01
• Primary Completion: 2016-03
• Study Completion: 2016-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-21
• Last Update Posted: 2016-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

Inclusion Criteria

• Body Mass Index between 18 to 27
• Accessible vein for blood sampling
• High probability for compliance and completion of the study
• No significant abnormalities in general physical examination
• ECG recording within normal limits
• Biochemical and haematological parameters within normal limits
• Subjects must agree to take effective contraceptive methods to prevent his partner from becoming pregnant during the time of first dose of study medication until one week of last dose administration

Exclusion Criteria

• History of hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study
• Clinically relevant abnormality in physical examination, ECG evaluation, urine test, blood chemistry or haematological test
• Tabacco use in any forms
• Regular consumer of alcohol
• Blood donation within 4 weeks prior to the start of the study
• Use of gliclazide within 4 weeks before the study
• Use of antidiabetic medications within 4 weeks before the study
• Volunteer in any other clinical drug study within 2 months prior to this study
• Hypersensitivity to gliclazide or other drugs in its class
• History of drug abude in any form

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Diamicron 80mg Tablet	Diamicron 80mg Tablet	During the study session, healthy male subjects will be administered a single oral dose of Diamicron 80 mg Tablet after an overnight fast of approximately 10 hours.
BF-Gliclazide Tablet 80mg	BF-Gliclazide Tablet 80mg	During the study session, healthy male subjects will be administered a single oral dose of BF-Gliclazide Tablet 80 mg after an overnight fast of approximately 10 hours.

Primary Outcome Measures

Name	Time	Method
Peak plasma concentration (Cmax) of gliclazide	72 hours
Area under the plasma concentration versus time curve (AUC) of gliclazide	72 hours

Secondary Outcome Measures

Name	Time	Method
Time to maximum concentration (Tmax) of gliclazide	72 hours
Elimination half-life (t1/2) of gliclazide	72 hours

Trial Locations

Locations (1)

Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong; 🇭🇰 New Territories, Hong Kong