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

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

November 29, 2018

Primary Completion Date

March 8, 2019

Study Completion Date

March 15, 2019

Conditions
Healthy
Interventions
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.

Trial Locations (1)

Unknown

General Hospital of the northern theater of the Chinese people's Liberation Army, Shenyang

All Listed Sponsors
lead

Sichuan Haisco Pharmaceutical Group Co., Ltd

INDUSTRY

NCT04556058 - A Study on the Bioequivalence of Perindopril Tert-butylamine Tablets Taken on an Empty Stomach in Healthy Subjects | Biotech Hunter | Biotech Hunter