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Clinical Bioequivalence Study on Two Metoprolol Tablet 100mg Formulations

NCT03082352 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-07-29

No results posted yet for this study

Summary

The purpose of the study is to compare the bioavailability of a generic product of metoprolol with that of a reference product when administered to healthy volunteers under fasting conditions. The test product is BF-Metoprolol Tablets 100mg manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited and the reference product is Betaloc Tablet 100mg. The plasma kinetic data of metoprolol obtained from two formulations will be used to access the interchangeability of the products.

Conditions

  • Healthy

Interventions

DRUG

BF-Metoprolol Tablet 100mg

BF-Metoprolol Tablet 100mg is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited

DRUG

Betaloc Tablet 100mg

Betaloc Tablet 100mg 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 University of Hong Kong

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

  • Brian Tomlinsion · Department of Medicine and Therapeutics, The Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-08-31
Primary Completion
2020-11-30
Completion
2020-12-31

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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 NCT03082352 on ClinicalTrials.gov