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Clinical Bioequivalence Study on Two Gliclazide 80mg Tablet Formulations

NCT02643329 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2016-07-25

No results posted yet for this study

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

Interventions

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

DRUG

Diamicron 80mg Tablet

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

Sponsors & Collaborators

  • Chinese University of Hong Kong

    collaborator OTHER

  • Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Vincent HL Lee · School of Pharmacy, The Chinese Univesity of Hong Kong

  • Risa Ozaki · Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong

  • Brian Tomlinson · Dept. of Medicine and Therapeutics, The Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-03-31
Completion
2016-04-30

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02643329 on ClinicalTrials.gov