- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04556058
A Study on the Bioequivalence of Perindopril Tert-butylamine Tablets Taken on an Empty Stomach in Healthy Subjects
September 14, 2020 updated by: Sichuan Haisco Pharmaceutical Group Co., Ltd
Bioequivalence Study of Fasting Oral Perindopril Tert-butylamine Tablets in Healthy Subjects With a Single-dose, Randomized, Open, Two-cycle, Crossover Trial Design
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Liaoning
-
Shenyang, Liaoning, China
- General Hospital of The Northern Theater of The Chinese People's Liberation Army
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy volunteers between the ages of 18 and 50 (including cut-off values), both male and female;
- Male weight ≥50kg, female weight ≥45kg, and body mass index (BMI) 19-26kg/m2 (including cut-off values);
- Sign the informed consent form voluntarily;
- Be able to maintain good communication with researchers and comply with various requirements of clinical trials.
Exclusion Criteria:
- 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;
- 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.
- 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;
- Blood donation or blood loss ≥ 400mL within 8 weeks before the first administration;
- People with a history of food or drug allergy, or allergies;
- Any clinically significant physical examination, vital signs, electrocardiogram or clinical laboratory measurement abnormalities during screening;
- 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;
- Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or Treponema pallidum antibody (TPPA) has a positive result;
- Those who have a history of drug abuse or drug dependence;
- People who have a history of fainting needles and blood, or who cannot tolerate venipuncture blood sampling and known serious bleeding tendency;
- Patients with resting systolic blood pressure ≤90 mmHg, ≥140mmHg, or diastolic blood pressure ≤60 mmHg, ≥90mmHg, or pulse (HR) ≤50bpm, ≥100bpm;
- 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;
- Patients with congenital galactosemia, glucose and galactose malabsorption syndrome, or lack of lactase;
- Subjects who have poor compliance or who the researcher thinks are not suitable for inclusion in the group.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum drug concentration (Cmax) of Perindopril
Time Frame: Before administration (within 2 hours) and 10 minutes to 72 hours after administration
|
Before administration (within 2 hours) and 10 minutes to 72 hours after administration
|
Area under the plasma concentration versus time curve (AUC0-∞、AUC0-t)of Perindopril
Time Frame: Before administration (within 2 hours) and 10 minutes to 72 hours after administration
|
Before administration (within 2 hours) and 10 minutes to 72 hours after administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to reach maximum plasma concentration(Tmax) of Perindopril and Perindoprilat
Time Frame: Before administration (within 2 hours) and 10 minutes to 72 hours after administration
|
Before administration (within 2 hours) and 10 minutes to 72 hours after administration
|
Terminal elimination half-life(t1/2 )of Perindopril and Perindoprilat
Time Frame: Before administration (within 2 hours) and 10 minutes to 72 hours after administration
|
Before administration (within 2 hours) and 10 minutes to 72 hours after administration
|
Maximum drug concentration (Cmax) of Perindoprilat
Time Frame: fore administration (within 2 hours) and 10 minutes to 72 hours after administration
|
fore administration (within 2 hours) and 10 minutes to 72 hours after administration
|
Area under the plasma concentration versus time curve (AUC0-∞、AUC0-t)of Perindoprilat
Time Frame: Before administration (within 2 hours) and 10 minutes to 72 hours after administration
|
Before administration (within 2 hours) and 10 minutes to 72 hours after administration
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse event rate
Time Frame: from the screening to 18 days post-dose
|
Adverse events are summarized according to the system organ classification and standard name, and the system organ classification and standard name are arranged in descending order of the frequency of the tested preparation group
|
from the screening to 18 days post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 29, 2018
Primary Completion (Actual)
March 8, 2019
Study Completion (Actual)
March 15, 2019
Study Registration Dates
First Submitted
August 25, 2020
First Submitted That Met QC Criteria
September 14, 2020
First Posted (Actual)
September 21, 2020
Study Record Updates
Last Update Posted (Actual)
September 21, 2020
Last Update Submitted That Met QC Criteria
September 14, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SZYQ-BE-2018-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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