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NCT04885660 Clinical Trial

Bioequivalence Evaluation of Two Fixed-dose Combination of Lisinopril 10mg/Levamlodipine Besylate 5mg in Healthy Chinese Subjects

Therapeutic Equivalency Clinical Trial

Official title:
Bioequivalence Study of Compound Lisinopril Tablets

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04885660
Other study ID # SR-BE-001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 12, 2018
Est. completion date November 20, 2019

Study information
Verified date May 2021
Source The Affiliated Hospital of Qingdao University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The bioavailability of compound lisinopril tablets (specification: lisinopril 10mg / amlodipine 5mg) developed by Sichuan shangrui biomedical Co., Ltd. was compared with that of reference compound lisinopril tablets (specification: lisinopril 10mg / amlodipine 5mg) produced by Hungary Gedeon Richter Pharmaceutical Co., Ltd.The bioequivalence of single dose of test preparation and reference preparation was evaluated in heathy subjects under fasting and fed conditions.

Recruitment information / eligibility
Status Completed
Enrollment 92
Est. completion date November 20, 2019
Est. primary completion date November 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 1.Healthy male and female aged over 18years 2.Subjects willing to provide written informed consent and to adhere to protocol requirements 3.Subject's weight within normal range according to normal values for Body Mass Index (19.00 to 26.00 kg/m2 (both inclusive)), males with minimum of 50 kg weight, females with minimum of 45kg weight. 4.Subjects have not clinically significant abnormalities, including vital signs, physical examinations, laboratory tests, and ECG as determined by clinical examination Exclusion Criteria: - 1.History or presence of significant cardiovascular, Urogenital, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder 2.Allergic constitution(Allergic to two or more substances) or hypersensitivity to investigational product 3.History or presence of significant gastrointestinal inflammation /ulcer. or other medical history affecting drug absorption 4.Use of any drugs or herbal medicine within 14 days prior to the first dose 5.Can not follow approved birth control methods (a double barrier method) from the screening(Female subjects from two weeks prior to the screening) till 3 months after the last dose

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• compound lisinopril tablet
The subjects randomly received single oral administration of compound lisinopril tablet(Lisinopril 10mg/Levamlodipine besylate 5mg)
• compound lisinopril tablet(Lisonorm®)
The subjects randomly received single oral administration of compound lisinopril tablet(Lisonorm®)

Locations
Country Name City State
China The Affiliated Hospital of Qingdao University Qingdao Shandong

Sponsors (1)
Lead Sponsor Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Peak Plasma Concentration (Cmax) Evaluate the Cmax of Lenopril and amlodipine for test preparation and reference preparation 90 days
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