Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects
- Conditions
- Therapeutic Equivalency
- Interventions
- Drug: Extended Release Nifedipine Tablets 30 mg (Adalat® GITS)Drug: Extended Release Nifedipine Tablets 30 mg
- Registration Number
- NCT04438720
- Lead Sponsor
- Cao Yu
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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.
- Being allergy to the study medications, smoking, alcohol abuse.
- Participation in another clinical trial within 3 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Extended Release Nifedipine Tablets（Adalat® GITS） Extended Release Nifedipine Tablets 30 mg (Adalat® GITS) Extended Release Nifedipine reference formulation at a single dose of 30 mg Extended Release Nifedipine Tablets Extended Release Nifedipine Tablets 30 mg Extended Release Nifedipine test formulation at a single dose of 30 mg
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax) 60 days Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)0-t 60 days Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Area under the plasma concentration versus time curve (AUC)0-∞ 60 days Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
- Secondary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events 60 days Collection of adverse events
Incidence of abnormal blood pressure 60 days Monitor both systolic and diastolic blood pressure
Incidence of abnormal temperature 60 days Monitor the temperature
Incidence of abnormal pulse 60 days Temperature the pulse
Incidence of abnormal electrocardiogram waveform 60 days Electrocardiogram inspection
Trial Locations
- Locations (1)
Phase I Clinical Research Center
🇨🇳Qingdao, Shandong, China