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A Study on the Bioequivalence of Perindopril Tert-butylamine Tablets Taken on an Empty Stomach in Healthy Subjects

Healthy Clinical Trial

Official title:
Bioequivalence Study of Fasting Oral Perindopril Tert-butylamine Tablets in Healthy Subjects With a Single-dose, Randomized, Open, Two-cycle, Crossover Trial Design

Clinical Trial Summary

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

Clinical Trial Description

This single-center, randomized, open-lable, single-dose, two-cycle,cross-over design bioequivalence test was conducted in subjects under fasting conditions. Subjects were fasted for at least 10 hours overnight in each cycle，but can't ban their from drinking water.The next morning 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 washout period in fasted 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

Clinical Trial Details
NCT number NCT04556058
Study type Interventional
Source Sichuan Haisco Pharmaceutical Group Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date November 29, 2018
Completion date March 15, 2019
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