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Completed

NCT Number: NCT04885660

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

compound lisinopril tablet

Drug

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

compound lisinopril tablet(Lisonorm®)

Drug

The subjects randomly received single oral administration of compound lisinopril tablet(Lisonorm®)

Primary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: 90 days

    Evaluate the Cmax of Lenopril and amlodipine for test preparation and reference preparation

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Official study title

Bioequivalence Study of Compound Lisinopril Tablets

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
May 13, 2021
Registry last updated
May 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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