Clinical Bioequivalence Study on Two Gliclazide 80mg Tablet Formulations

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BF-Gliclazide Tablet 80mg; Drug: Diamicron 80mg Tablet

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• Hong Kong
  • New Territories, Hong Kong
    • Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: BF-Gliclazide Tablet 80mg; BF-Gliclazide Tablet is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited; Other Names: Gliclazide Tablet 80mg
Active Comparator: 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.	Drug: Diamicron 80mg Tablet; Diamicron 80mg Tablet is manufactured by Les Laboratoires Servier Industrie, France; Other Names: Gliclazide Tablet 80mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak plasma concentration (Cmax) of gliclazide	72 hours
Area under the plasma concentration versus time curve (AUC) of gliclazide	72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to maximum concentration (Tmax) of gliclazide	72 hours
Elimination half-life (t1/2) of gliclazide	72 hours

Collaborators and Investigators

• Sponsor: Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
• Collaborators: Chinese University of Hong Kong
• Investigators: Study Director: Risa Ozaki, Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong; Study Director: Brian Tomlinson, Dept. of Medicine and Therapeutics, The Chinese University of Hong Kong; Principal Investigator: Vincent HL Lee, School of Pharmacy, The Chinese Univesity of Hong Kong

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: December 28, 2015
• First Submitted That Met QC Criteria: December 29, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Estimate): July 25, 2016
• Last Update Submitted That Met QC Criteria: July 21, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Gliclazide
• Other Study ID Numbers: BABE-P14-095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study investigators and his/her study team members, domestic and foreign regulatory agencies, the IRB/EC involved in the study, healthcare providers who provide services to subjects in connection with this study, and laboratories and other individuals and organizations that analyze the subjects' protected health information in connection with this study have access to the data or study.