A Single Center, Single-dose, Double-blind, Randomized, Two Period Crossover, Two Stage Design to Determine Bioequivalence of Two Formulations Containing Hyoscine Butylbromide 10mg Sugar Coated Tablets, Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax)
研究概览
简要总结
Determine bioequivalence of two forumulations with hyoscine butylbromide 10mg sugar coated tablets.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 50 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
Hyoscine butylbromide SCT
干预措施: hyoscine butylbromide (Drug)
Hyoscine butylbromide
干预措施: hyoscine butylbromide (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax)
时间窗: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter
The maximum measured concentration of hyoscine butylbromide in plasma.
AUC Time Zero to Times of Last Quantifiable Concentration (AUC 0-t)
时间窗: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter
Area under the concentration-time curve of hyoscine butylbromide in plasma over the time interval from 0 to the last quantifiable data point (AUC0-t).
次要结局
- Area Under the Curve, for the Test Product, to the Time of the Maximum Concentration of the Reference Product and the Test Product (AUCReftmax)(Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter)
- Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC0-∞).(Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter)