NCT04556110

A Study on the Bioequivalence of Perindopril Tert-butylamine Tablets Taken on After Meals in Healthy Subjects

Bioequivalence Study of Oral Perindopril Tert-butylamine Tablets After Meal in Healthy Subjects With a Single-dose, Randomized, Open-lable, Four-cycle, Crossover Trial Design

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Perindopril tert-Butylamine tablets （ Produced by Haisco）	The trial was divided into four cycles, between of each cycle with a 14-day wash-out period.In the first cycle，subjects in experimental group took the test preparation Perindopril tert-butylamine after meal, and subjects in control group took the reference preparation ACERTIL® after meal; In the second cycle subjects in experimental group took the reference preparation ACERTIL® after meal , the trial preparation perindopril tert-butylamine was taken orally after meals for the subjects in control group ; the order of taking the medicines for the subjects in the third cycle was the same as that in the first cycle, and the taking order of the subjects in the fourth cycle was the same as that in the second cycle. A single oral administration was used for the four cycles, and the dose was 4 mg.
DRUG	Perindopril tert-Butylamine tablets（ACERTIL®）	The trial was divided into four cycles, between of each cycle with a 14-day wash-out period.In the first cycle，subjects in experimental group took the test preparation Perindopril tert-butylamine after meal, and subjects in control group took the reference preparation ACERTIL® after meal; In the second cycle subjects in experimental group took the reference preparation ACERTIL® after meal , the trial preparation perindopril tert-butylamine was taken orally after meals for the subjects in control group ; the order of taking the medicines for the subjects in the third cycle was the same as that in the first cycle, and the taking order of the subjects in the fourth cycle was the same as that in the second cycle. A single oral administration was used for the four cycles, and the dose was 4 mg.

Timeline

• Start date: 2018-11-20
• Primary completion: 2019-01-16
• Completion: 2019-03-15
• First posted: 2020-09-21
• Last updated: 2020-09-21

Locations

1 site across 1 country: China