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

NCT ID: NCT04556110

Last Updated: 2020-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-20
• Study Completion Date: 2019-03-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Perindopril tert-Butylamine tablets （ Produced by Haisco）

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Perindopril tert-Butylamine tablets（ACERTIL®）

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy volunteers between the ages of 18 and 50 (including cut-off values), both male and female;

2. Male weight ≥50kg, female weight ≥45kg, and body mass index (BMI) 19-26kg/m2 (including cut-off values);

3. Sign the informed consent form voluntarily;

4. Be able to maintain good communication with researchers and comply with various requirements of clinical trials.

Exclusion Criteria

1. People who is addicted to alcohol, tobacco,(drink 14 units of alcohol per week within the first month of enrollment: 1 unit = 285 ml of beer, or 25 ml of spirits, or 1 glass of wine; average daily smoking in the 3 months before screening ≥5) and/or those who cannot ban smoking and alcohol during the trial; or those who have a positive result alcohol breath trial;

2. Use any prescription drugs (such as antihypertensive drugs) within 4 weeks before screening, or use any over-the-counter drugs (vitamins, Chinese herbal tonics) within 2 weeks before screening, or take foods that affect metabolism within 2 weeks before screening, such as grapefruit or a drink containing grapefruit (acetaminophen can be used, but it must be recorded in the concomitant medication of CRF); or the subject refused to stop using foods that affect CYP1A2 during the trial, such as coffee, tea, cola, chocolate, etc.

3. Those who have used any drugs with a long half-life that may affect this study, or have participated in any drug clinical trials as subjects in the past 3 months;

4. Blood donation or blood loss ≥ 400mL within 8 weeks before the first administration;

5. People with a history of food or drug allergy, or allergies;

6. Any clinically significant physical examination, vital signs, electrocardiogram or clinical laboratory measurement abnormalities during screening;

7. Suffer from blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, mental abnormality, metabolic abnormality or any other chronic or serious disease history or existing disease that may affect the results of the study Those with the aforementioned systemic diseases;

8. Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or Treponema pallidum antibody (TPPA) has a positive result;

9. Those who have a history of drug abuse or drug dependence;

10. People who have a history of fainting needles and blood, or who cannot tolerate venipuncture blood sampling and known serious bleeding tendency;

11. Patients with resting systolic blood pressure ≤90 mmHg, ≥140mmHg, or diastolic blood pressure ≤60 mmHg, ≥90mmHg, or pulse (HR) ≤50bpm, ≥100bpm;

12. Pregnant or lactating women, or female subjects whose pregnancy test results are positive; subjects (or their partners) have birth plans or sperm and egg donors during the entire trial period and within 3 months after the end of the study; trial Those who are unwilling to take one or more physical contraceptive measures during the period and within 3 months after the end of the study;

13. Patients with congenital galactosemia, glucose and galactose malabsorption syndrome, or lack of lactase;

14. Subjects who have poor compliance or who the researcher thinks are not suitable for inclusion in the group.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sichuan Haisco Pharmaceutical Group Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Shenyang, Liaoning, China

Countries

China

Other Identifiers

SZYQ-BE-2018-005

Identifier Type: -

Identifier Source: org_study_id