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Clinical Bioequivalence Study on Two Methyldopa Tablet 250mg Formulations

NCT03210025 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2018-01-18

No results posted yet for this study

Summary

The objective of the study is to compare the bioavailability of a generic product of methyldopa with that of a reference product when administered to healthy volunteers under fasting condition. The test product is BF-Methyldopa Tablet 250mg (HK Reg. No. HK-62917) manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited, and the reference product is Metopa Tab 250mg (HK Reg. No. HK-44620). The plasma pharmacokinetic data of Methyldopa obtained from two formulations will be used to access the interchangeability of the products.

Conditions

  • Healthy

Interventions

DRUG

BF-Methyldopa 250mg Tablet

BF-Methyldopa 250mg Tablet is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited

DRUG

Metopa Tab 250mg

Metopa Tab 250mg is manufactured by APT

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
2017-09-20
Primary Completion
2017-10-15
Completion
2017-10-15

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 NCT03210025 on ClinicalTrials.gov