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Clinical Bioequivalence Study on Two Lisinopril Tablets 20mg Formulations

NCT03599466 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-01-16

No results posted yet for this study

Summary

The objective of the study is to compare the bioavailability of a generic product of lisinopril with that of a reference product when administered to healthy volunteers under fasting condition. The test product is BF-Lisinopril Tablet 20mg (HK-63564) manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited, and the reference product is Zestril Tab 20mg (HK-30515). The bioequivalence or bioinequivalence of the test and reference formulations will be assessed and concluded based on the plasma pharmacokinetic data of lisinopril, as well as WHO guidelines on registration requirements to establish interchangeability.

Conditions

  • Healthy

Interventions

DRUG

BF-Lisinopril Tablets 20mg

BF-Lisinopril Tablets 20mg is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited

DRUG

Zestril Tab 20mg

Zestril Tab 20mg will be used as a reference drug in this 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
2019-10-31
Primary Completion
2020-03-31
Completion
2020-04-30

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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 NCT03599466 on ClinicalTrials.gov