Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects

Study Overview
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Brief Summary
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According to the relevant provisions of bioequivalence test, nifedipine sustained-release tablets (test preparation, t, 30mg / tablet) provided by Guangzhou bostao controlled release pharmaceutical Co., Ltd. were compared with Adalat ® GITS (reference preparation, R, 30mg / tablet) produced by Bayer Pharma AG to evaluate the bioequivalence of single dose in healthy subjects under fasting conditions.

Official Title
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Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects: A Single-dose and Two-period Crossover Study

Conditions
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Therapeutic Equivalency

Intervention / Treatment
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* Drug: Extended Release Nifedipine Tablets 30 mg
* Drug: Extended Release Nifedipine Tablets 30 mg (Adalat® GITS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female aged 18-45. The body mass index is in the range of 18.6-28.5 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg. The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test. The subjects have no family planning within 3 months and could select contraceptive method. Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily. Exclusion Criteria: Being allergy to the study medications, smoking, alcohol abuse. Participation in another clinical trial within 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extended Release Nifedipine Tablets（Adalat® GITS）<br>Extended Release Nifedipine reference formulation at a single dose of 30 mg | Drug: Extended Release Nifedipine Tablets 30 mg (Adalat® GITS)<br>* The subjects randomly received single oral administration of extended release nifedipine tablets 30 mg.<br>|
| Experimental: Extended Release Nifedipine Tablets<br>Extended Release Nifedipine test formulation at a single dose of 30 mg | Drug: Extended Release Nifedipine Tablets 30 mg<br>* The subjects randomly received single oral administration of extended release nifedipine tablets 30 mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) | Evaluation of Peak Plasma Concentration (Cmax) | 60 days | 
| Area under the plasma concentration versus time curve (AUC)0-t | Evaluation of Area under the plasma concentration versus time curve (AUC)0-t | 60 days | 
| Area under the plasma concentration versus time curve (AUC)0-∞ | Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞ | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | Collection of adverse events | 60 days | 
| Incidence of abnormal blood pressure | Monitor both systolic and diastolic blood pressure | 60 days | 
| Incidence of abnormal temperature | Monitor the temperature | 60 days | 
| Incidence of abnormal pulse | Temperature the pulse | 60 days | 
| Incidence of abnormal electrocardiogram waveform | Electrocardiogram inspection | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extended Release Nifedipine Tablets