Relative Bioavailability of 5 mg BI 10773 Administered Twice Daily Compared to 10 mg BI 10773 Given Once Daily After Multiple Oral Doses in Healthy Male and Female Volunteers (an Open-label, Randomised, Crossover, Clinical Phase I Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) of BI 10773.
研究概览
简要总结
To investigate the influence of different dosage regimen (5 mg twice daily versus 10 mg once daily) on the steady state pharmacokinetics and pharmacodynamics of BI 10773 administered orally
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
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
Treatment A: Empagliflozin
5 mg bid
干预措施: Empagliflozin (Drug)
Treatment B: Empagliflozin
10 mg qd
干预措施: Empagliflozin (Drug)
结局指标
主要结局
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) of BI 10773.
时间窗: up to 168 hours
AUC (area under the concentration-time curve of the analyte in plasma) - AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) for 10 mg BI 10773 QD.
时间窗: up to 168 hours
AUC (area under the concentration-time curve of the analyte in plasma) - AUC0-24,ss (area under the concentration-time curves of the analyte in plasma at steady-state over two dosing intervals) for 5 mg BI 10773 BID after the morning dose on Day 5.
时间窗: up to 168 hours
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) of BI 10773.
时间窗: up to 168 hours
次要结局
- tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval t) of BI 10773.(up to 168 hours)
- C12,N (concentration of analyte in plasma at 12 hours post-drug administration after administration of the Nth dose for the BID regimen) of BI 10773.(up to 168 hours)
- CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state) of BI 10773.(up to 168 hours)
- PTF (percentage peak-trough fluctuation)(up to 168 hours)
- C24,N (concentration of analyte in plasma at 24 hours post-drug administration after administration of the Nth dose for the QD regimen) of BI 10773.(up to 168 hours)
- Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) of BI 10773(up to 168 hours)
- Cavg (average concentration of the analyte in plasma at steady state) of BI 10773(up to 168 hours)
- ¿z,ss (terminal half-life of the analyte in plasma at steady state) of BI 10773(up to 168 hours)
- MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration) of BI 10773.(up to 168 hours)
- Vz/F,ss (apparent volume of distribution during the terminal phase tau z at steady state following extravascular administration) of BI 10773.(up to 168 hours)
- t½,ss (terminal half-life of the analyte in plasma at steady state) of BI 10773(up to 168 hours)