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Clinical Bioequivalence Study on Two Amlodipine Tablet 10mg Formulations

NCT02707913 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2016-09-07

No results posted yet for this study

Summary

The purpose of the study is to compare the bioavailability of a generic product of amlodipine with that of a reference product when administered to healthy volunteers under fasting conditions. The test product name is BF-Amlodipine Tablet 10mg manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited, and the reference product is Norvasc Tablet 10mg. The plasma pharmacokinetic data of amlodipine obtained from two formulations will be used to access the interchangeability of the products

Conditions

  • Healthy

Interventions

DRUG

BF-Amlodipine Tablet 10mg

BF-Amlodipine Tablet 10mg is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited

DRUG

Norvasc Tablet 10mg

Norvasc Tablet 10mg will be used as a comparator drug for the BE study

Sponsors & Collaborators

  • Chinese University of Hong Kong

    collaborator OTHER

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

    lead INDUSTRY

Principal Investigators

  • Zhong ZUO · 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
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-08-31
Completion
2016-09-30

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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 NCT02707913 on ClinicalTrials.gov