Relative Bioavailability of Empagliflozin Tablets After Different Administration Modi in Healthy Male and Female Subjects (Randomised, Two-period Crossover Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
研究概览
简要总结
This trial is conducted to test how empagliflozin is taken up in the body when taken as a whole tablet or dissolved in water and mixed with food.
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 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
Treatment sequence A
R - reference treatment: Empagliflozin tablet, administered to subjects in fasting state with water T - test treatment: Empagliflozin dispersed in water and mixed with food, administered to subjects in fasting state with water
干预措施: Empagliflozin (Drug)
Treatment sequence B
T - test treatment: Empagliflozin dispersed in water and mixed with food, administered to subjects in fasting state with water R - reference treatment: Empagliflozin tablet, administered to subjects in fasting state with water
干预措施: Empagliflozin (Drug)
结局指标
主要结局
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
时间窗: up to 3 days
Maximum measured concentration of the analyte in plasma (Cmax)
时间窗: up to 3 days
次要结局
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)(up to 3 days)