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Clinical Trial Summary

In order to evaluate the bioequivalence of the test preparation and reference preparation of perindopril tert-butylamine tablets after meal and their safety in Chinese adult healthy subjects.


Clinical Trial Description

This single-center, randomized, open, single-dose, four-cycle,cross-over design bioequivalence test was conducted in subjects after meal conditions. Subjects were fasted for at least 10 hours over the night in each cycle,but can't ban their from drinking water.The next morning,after eating a high-fat and high-calorie meal for 30 minutes, according to test-reference (TR) or Reference-test (RT) sequential oral perindopril tert-butylamine tablets (4 mg, 240 mL warm water). Each period was separated with a 14-day wash-out period in after meal trials. The blood concentrations of perindopril and perindoprilat in qualified subjects were tested. Safety assessment includes vital signs examination, physical examination, laboratory safety examination, coagulation examination, electrocardiogram and adverse event reports. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04556110
Study type Interventional
Source Sichuan Haisco Pharmaceutical Group Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date November 20, 2018
Completion date March 15, 2019

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