NCT04556058

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

Bioequivalence Study of Fasting Oral Perindopril Tert-butylamine Tablets in Healthy Subjects With a Single-dose, Randomized, Open, Two-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 preparations and reference preparations of perindopril tert-butylamine tablets after meal and their safety in Chinese adult healthy subjects.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Perindopril tert-Butylamine tablets （ Produced by Haisco）	The trial is divided into two cycles, between of two cycle with a 14-day wash-out period. In the first cycle, the subjects in experimental group took the test preparation perindopril tert-butylamine tablets on an empty stomach, and the subjects in control group took the reference preparation ACERTIL® on an empty stomach. The subjects of the two groups exchanged on the 15th day after the first administration take medicine. A single oral administration was used for both cycles, and the dose was 4 mg.
DRUG	Perindopril tert-Butylamine tablets（ACERTIL®）	The trial is divided into two cycles, between of two cycle with a 14-day wash-out period. In the first cycle, the subjects in experimental group took the test preparation perindopril tert-butylamine tablets on an empty stomach, and the subjects in control group took the reference preparation ACERTIL® on an empty stomach. The subjects of the two groups exchanged on the 15th day after the first administration take medicine. A single oral administration was used for both cycles, and the dose was 4 mg.

Timeline

• Start date: 2018-11-29
• Primary completion: 2019-03-08
• Completion: 2019-03-15
• First posted: 2020-09-21
• Last updated: 2020-09-21

Locations

1 site across 1 country: China