The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003, China
NCT Number: NCT04885660
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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Notify Me18 year and older
All sexes
Interventional
Phase 1
Qingdao, Shandong, 266003, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
4.Subjects have not clinically significant abnormalities, including vital signs, physical examinations, laboratory tests, and ECG as determined by clinical examination
Exclusion criteria
The subjects randomly received single oral administration of compound lisinopril tablet(Lisinopril 10mg/Levamlodipine besylate 5mg)
The subjects randomly received single oral administration of compound lisinopril tablet(Lisonorm®)
Time frame: 90 days
Evaluate the Cmax of Lenopril and amlodipine for test preparation and reference preparation
The Affiliated Hospital of Qingdao University
Other
Bioequivalence Study of Compound Lisinopril Tablets
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