Relative Bioavailability of Single Doses of Vicadrostat and Empagliflozin Administered Alone Compared to Combined Administration to Healthy Male Subjects (an Open Label, Randomised, Three-way Crossover Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve of vicadrostat in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
研究概览
简要总结
The main objective of this trial is to investigate the relative bioavailability of vicadrostat and empagliflozin when administered in combination or individually.
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
- 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
Treatment sequence A: R1-R2-T
Reference 1 (R1): vicadrostat Reference 2 (R2): empagliflozin Test (T): vicadrostat and empagliflozin taken together
干预措施: Vicadrostat (Drug)
Treatment sequence A: R1-R2-T
Reference 1 (R1): vicadrostat Reference 2 (R2): empagliflozin Test (T): vicadrostat and empagliflozin taken together
干预措施: Jardiance® (Drug)
Treatment sequence B: R2-T-R1
Reference 1 (R1): vicadrostat Reference 2 (R2): empagliflozin Test (T): vicadrostat and empagliflozin taken together
干预措施: Vicadrostat (Drug)
Treatment sequence B: R2-T-R1
Reference 1 (R1): vicadrostat Reference 2 (R2): empagliflozin Test (T): vicadrostat and empagliflozin taken together
干预措施: Jardiance® (Drug)
Treatment sequence C: T-R1-R2
Reference 1 (R1): vicadrostat Reference 2 (R2): empagliflozin Test (T): vicadrostat and empagliflozin taken together
干预措施: Vicadrostat (Drug)
Treatment sequence C: T-R1-R2
Reference 1 (R1): vicadrostat Reference 2 (R2): empagliflozin Test (T): vicadrostat and empagliflozin taken together
干预措施: Jardiance® (Drug)
结局指标
主要结局
Area under the concentration-time curve of vicadrostat in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
时间窗: Reference 1 (Days 1, 2 and 3), Test (Days 1, 2 and 3)
Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
时间窗: Reference 2 (Days 1, 2, 3 and 4), Test (Days 1, 2, 3 and 4)
Maximum measured concentration of vicadrostat in plasma (Cmax)
时间窗: Reference 1 (Days 1, 2 and 3), Test (Days 1, 2 and 3)
Maximum measured concentration of empagliflozin in plasma (Cmax)
时间窗: Reference 2 (Days 1, 2, 3 and 4), Test (Days 1, 2, 3 and 4)
次要结局
- Area under the concentration-time curve of vicadrostat in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz )(Reference 1 (Days 1, 2 and 3), Test (Days 1, 2 and 3))
- Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)(Reference 2 (Days 1, 2, 3 and 4), Test (Days 1, 2, 3 and 4))