Clinical Bioequivalence Study on Two Lisinopril Tablets 20mg Formulations

• Status: Unknown status
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
• Collaborator: Chinese University of Hong Kong
• Treatments: Lisinopril

Criteria

Inclusion Criteria:

• Male and non-pregnant female, 18 to 55 years of age

• Body Mass Index between 18 to 30 kg/m2

• Accessible vein for blood sampling

• High probability for compliance and completion of the study

• Female subjects must agree to practice abstinence or take effective contraceptive methods to prevent pregnancy from the start of the screening and until two weeks of last dose administration.

Exclusion Criteria:

• Clinically significant hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study

• Clinically significant abnormality in physical examination, vital sign, laboratory test results, ECG evaluation, urine test, blood chemistry or haematological test

• Regular consumption of tobacco used in any forms

• Regular consumer of alcohol (more than one drink per day)

• Blood donation within 4 weeks prior to the start of the study

• Use of lisinopril within 4 weeks before the study

• Use of antihypertensive medications or angiotensin-converting enzyme (ACE) inhibitors within 4 weeks before the study

• Volunteer in any other clinical drug study within 2 months prior to this study

• Hypersensitivity to lisinopril or other drugs in its class

• History of drug abuse in any form

• Female subjects who are breastfeeding or pregnant