Clinical Bioequivalence Study on Two Gliclazide 80mg Tablet Formulations

NCT02643329 | Completed Phase 1 DMC

• 1 other identifier: BABE-P14-095
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Peak plasma concentration (Cmax) of gliclazide

  72 hours

• Area under the plasma concentration versus time curve (AUC) of gliclazide

  72 hours

Secondary Outcomes (2)

• Time to maximum concentration (Tmax) of gliclazide

  72 hours

• Elimination half-life (t1/2) of gliclazide

  72 hours

Study Arms (2)

BF-Gliclazide Tablet 80mg

EXPERIMENTAL

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

Diamicron 80mg Tablet

ACTIVE COMPARATOR

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

Interventions

BF-Gliclazide Tablet 80mg DRUG

BF-Gliclazide Tablet is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited

Also known as: Gliclazide Tablet 80mg

BF-Gliclazide Tablet 80mg

Diamicron 80mg Tablet DRUG

Diamicron 80mg Tablet is manufactured by Les Laboratoires Servier Industrie, France

Also known as: Gliclazide Tablet 80mg

Diamicron 80mg Tablet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited: lead
• Chinese University of Hong Kong: collaborator

Study Sites (1)

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

New Territories, Hong Kong

Location

MeSH Terms

Interventions

Gliclazide; Tablets

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfonylurea Compounds; Urea; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Vincent HL Lee

  School of Pharmacy, The Chinese Univesity of Hong Kong

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2015
• First Posted: December 31, 2015
• Study Start: January 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 25, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)