Status:
COMPLETED
Bioequivalence Evaluation of Two Fixed-dose Combination of Lisinopril 10mg/Levamlodipine Besylate 5mg in Healthy Chinese Subjects
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Therapeutic Equivalency
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 lis...
Eligibility Criteria
Inclusion
- \- 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.
- Subjects have not clinically significant abnormalities, including vital signs, physical examinations, laboratory tests, and ECG as determined by clinical examination
Exclusion
- 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
Key Trial Info
Start Date :
October 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2019
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04885660
Start Date
October 12 2018
End Date
November 20 2019
Last Update
May 13 2021
Active Locations (1)
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1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266003