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Clinical Bioequivalence Study on Two Lisinopril Tablets 20mg Formulations

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ClinicalTrials.gov Identifier: NCT03599466
Recruitment Status : Not yet recruiting
First Posted : July 25, 2018
Last Update Posted : January 16, 2019
Sponsor:
Collaborator:
Chinese University of Hong Kong
Information provided by (Responsible Party):
Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: BF-Lisinopril Tablets 20mg Drug: Zestril Tab 20mg Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Other
Official Title: Clinical Bioequivalence Study on Two Lisinopril Tablets 20mg Formulations
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Lisinopril

Arm Intervention/treatment
Experimental: 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.
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

Active Comparator: 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.
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




Primary Outcome Measures :
  1. Peak plasma concentration (Cmax) of Lisinopril [ Time Frame: 48 hours ]
    Peak drug concentration, obtained directly from the original concentration-time data.

  2. Area under the plasma concentration versus time curve (AUC) of Lisinopril [ Time Frame: 48 hours ]
    Area under the concentration-time curve from time zero to the last sampling time.


Secondary Outcome Measures :
  1. Time to maximum concentration (Tmax) of Lisinopril [ Time Frame: 48 hours ]
    Time to peak drug concentration, obtained directly from the original concentration-time data.

  2. Elimination half-life (t1/2) of Lisinopril [ Time Frame: 48 hours ]
    Terminal elimination half-life, calculated as 0.693/(the terminal phase elimination rate constant that can be obtained using WinNonlin)



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599466


Contacts
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Contact: Evelyn YM Chau (852) 26323377 chauevelyn@cuhk.edu.hk
Contact: Benny SP Fok (852) 26323377 bfok@cuhk.edu.hk

Sponsors and Collaborators
Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
Chinese University of Hong Kong
Investigators
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Principal Investigator: Zhong Zuo School of Pharmacy, The Chinese University of Hong Kong
Study Director: Riza Ozaki Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong
Study Director: Brian Tomlinsion Department of Medicine and Therapeutics, The Chinese University of Hong Kong

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Responsible Party: Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
ClinicalTrials.gov Identifier: NCT03599466     History of Changes
Other Study ID Numbers: BABE-P15-099
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study investigators and his/her study team members, domestic and foreign regulatory agencies, members of ethics committee and health authorities, monitors and auditors relevant to conduct of this clinical study will be granted free access to subject's data. The relevant technical, medical, pharmaceutical, biological and chemical personnel of the sponsor will have access to the case report forms.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lisinopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs