A Single-Dose, Comparative Bioavailability Study of Telmisartan/Amlodipine 80 mg/10 mg Tablets Versus Micardis 80 mg Tablets With Norvasc 10 mg Tablets Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-time Curve of Plasma Amlodipine From 0 to 72 Hours (AUC72)
研究概览
简要总结
This study will be an open-label, randomized, two-treatment, two-period, two-sequence crossover study to evaluate the bioequivalence of the amlodipine component of Boehringer Ingelheim Pharma GmbH & Co. KGs 80 mg telmisartan/10 mg amlodipine fixed dose combination tablet to the corresponding mono-component amlodipine tablets, 10 mg (Pfizers Norvasc).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Telmisartan/Amlodipine Fixed Dose
Telmisartan/Amlodipine medium fixed dose combination tablet once daily.
干预措施: Telmisartan/Amlodipine Combination Tablet (Drug)
Amlodipine Monocomponent
Amlodipine Monocomponent 10mg tablet once daily
干预措施: Amlodipine Monocomponent (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve of Plasma Amlodipine From 0 to 72 Hours (AUC72)
时间窗: Day 1, Day 22
Area under the analyte concentration versus time curve from time zero to 72 hours as calculated by the linear trapezoidal method
Maximum Observed Plasma Concentration (Cmax) of Amlodipine
时间窗: Day 1, Day 22
次要结局
- Time of Maximum Concentration of Amlodipine (TMAX)(Day 1, Day 22)