A Study on the Bioequivalence of Perindopril Tert-butylamine Tablets Taken on After Meals in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Perindopril tert-Butylamine tablets （ Produced by Haisco）; Perindopril tert-Butylamine tablets（ACERTIL®）
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Intervention MeSH terms: Perindopril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Perindopril tert-butylamine; Bioequivalence study; After meal