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Clinical Bioequivalence Study on Two Gliclazide 80mg Tablet Formulations

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02643329
First Posted: December 31, 2015
Last Update Posted: July 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Chinese University of Hong Kong
Information provided by (Responsible Party):
Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
  Purpose
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.

Condition Intervention Phase
Healthy Drug: BF-Gliclazide Tablet 80mg Drug: Diamicron 80mg Tablet Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Clinical Bioequivalence Study on Two Gliclazide 80mg Tablet Formulations

Further study details as provided by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited:

Primary Outcome Measures:
  • Peak plasma concentration (Cmax) of gliclazide [ Time Frame: 72 hours ]
  • Area under the plasma concentration versus time curve (AUC) of gliclazide [ Time Frame: 72 hours ]

Secondary Outcome Measures:
  • Time to maximum concentration (Tmax) of gliclazide [ Time Frame: 72 hours ]
  • Elimination half-life (t1/2) of gliclazide [ Time Frame: 72 hours ]

Enrollment: 17
Study Start Date: January 2016
Study Completion Date: April 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Gliclazide Tablet 80mg

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643329


Locations
Hong Kong
Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong
New Territories, Hong Kong
Sponsors and Collaborators
Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
Chinese University of Hong Kong
Investigators
Principal Investigator: Vincent HL Lee School of Pharmacy, The Chinese Univesity of Hong Kong
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
  More Information

Responsible Party: Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
ClinicalTrials.gov Identifier: NCT02643329     History of Changes
Other Study ID Numbers: BABE-P14-095
First Submitted: December 28, 2015
First Posted: December 31, 2015
Last Update Posted: July 25, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Additional relevant MeSH terms:
Gliclazide
Hypoglycemic Agents
Physiological Effects of Drugs