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

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

November 20, 2018

Primary Completion Date

January 16, 2019

Study Completion Date

March 15, 2019

Conditions
Healthy
Interventions
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.

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

NCT04556110 - A Study on the Bioequivalence of Perindopril Tert-butylamine Tablets Taken on After Meals in Healthy Subjects | Biotech Hunter | Biotech Hunter