Single Center, Single Dose, Open-label, Randomized, Two-way Crossover Study to Determine Bioequivalence of Two Formulations Containing Tamsulosin HCl 04.mg MR Capsules in at Least 30 Healthy Male Subjects Under Fed Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 主要终点
- Maximum Measured Concentration (Cmax)
研究概览
简要总结
Two tamsulosin HClformulations will be tested in fed state
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 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
Tamsulosin HCl
干预措施: Tamsulosin HCL (Drug)
Tamsulosin
干预措施: tamsulosin (Astellas) (Drug)
结局指标
主要结局
Maximum Measured Concentration (Cmax)
时间窗: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Maximum measured concentration of analyte in plasma (Cmax)
Area Under the Concentration-time Curve From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)
时间窗: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)
Area Under the Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-inf)
时间窗: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).
次要结局
- Time to Maximum Plasma Concentration (Tmax)(Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration)
- Terminal Elimination Rate Constant (λz)(Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration)
- Apparent Terminal Elimination Half-life (t1/2)(Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration)