Clinical Bioequivalence Study on Two Lisinopril Tablets 20mg Formulations

NCT ID: NCT03599466

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2020-04-30

Brief 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.

Detailed Description

It is planned to enroll 16 to 30 healthy subjects, with an aim to obtain at least 12 evaluable subjects. The study design is a single-dose, two-treatment, two-period, two-sequence crossover with a washout period of one to two weeks. During each study session, the subjects will be administered a single dose of 20mg lisinopril (one BF-Lisinopril tablets 20mg or one Zestril Tab 20mg) after an overnight fast of approximately 10 hours. Venous blood samples will be collected at pre-dose (0h) and at 1,2,4,5,6,7,8,9,10,12,24 and 48 hours post-dose (13 time points). The plasma concentrations of lisinopril will be determined by a validated assay. The non-compartmental method will be used to analyze the plasma concentration-time data and calculate the main pharmacokinetic parameters such as Cmax, Tmax, AUC0-last, AUC0-inf, and T1/2. ANOVA will be calculated on logarithmically transformed Cmax, AUC0-last and AUC0-inf. The two one sided tests will be used to calculate the 90% confidence intervals for the mean difference in AUC0-last, AUC0-inf and Cmax and to assess the bioequivalence of the two products.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

BF-Lisinopril Tablets 20mg

During the study session, the subjects will be administered a single dose of BF-Lisinopril Tablet 20mg after an overnight fast of approximately 10 hours.

Group Type: EXPERIMENTAL

BF-Lisinopril Tablets 20mg

Intervention Type: DRUG

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

Zestril Tab 20mg

Intervention Type: DRUG

Zestril Tab 20mg will be used as a reference drug in this study

Zestril Tab 20mg

During the study session, the subjects will be administered a single dose of Zestril Tab 20mg after an overnight fast of approximately 10 hours.

Group Type: ACTIVE_COMPARATOR

BF-Lisinopril Tablets 20mg

Intervention Type: DRUG

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

Zestril Tab 20mg

Intervention Type: DRUG

Zestril Tab 20mg will be used as a reference drug in this study

Interventions

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

Intervention Type: DRUG

Zestril Tab 20mg

Zestril Tab 20mg will be used as a reference drug in this study

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: collaborator

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhong Zuo

Role: PRINCIPAL_INVESTIGATOR

School of Pharmacy, The Chinese University of Hong Kong

Riza Ozaki

Role: STUDY_DIRECTOR

Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong

Brian Tomlinsion

Role: STUDY_DIRECTOR

Department of Medicine and Therapeutics, The Chinese University of Hong Kong

Central Contacts

Evelyn YM Chau

Role: CONTACT

chauevelyn@cuhk.edu.hk

(852) 26323377

Benny SP Fok

Role: CONTACT

bfok@cuhk.edu.hk

(852) 26323377

Other Identifiers

BABE-P15-099

Identifier Type: -

Identifier Source: org_study_id