Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects: A Single-dose and Two-period Crossover Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female aged 18-
- •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.
排除标准
- •Being allergy to the study medications, smoking, alcohol abuse.
- •Participation in another clinical trial within 3 months.
研究组 & 干预措施
Extended Release Nifedipine Tablets（Adalat® GITS）
Extended Release Nifedipine reference formulation at a single dose of 30 mg
干预措施: Extended Release Nifedipine Tablets 30 mg (Adalat® GITS) (Drug)
Extended Release Nifedipine Tablets
Extended Release Nifedipine test formulation at a single dose of 30 mg
干预措施: Extended Release Nifedipine Tablets 30 mg (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: 60 days
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)0-t
时间窗: 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-∞
时间窗: 60 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
次要结局
- Incidence of Treatment-Emergent Adverse Events(60 days)
- Incidence of abnormal blood pressure(60 days)
- Incidence of abnormal temperature(60 days)
- Incidence of abnormal pulse(60 days)
- Incidence of abnormal electrocardiogram waveform(60 days)
研究者
Cao Yu
Director, Head of Phase I clinical research center, Principal Investigator, Clinical Professor.
The Affiliated Hospital of Qingdao University