Relative Bioavailability of BI 10773 Given Alone and Together With Verapamil - an Open-label, Randomised, Crossover Trial in Healthy Subjects
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
- Area Under the Curve 0 to Infinity (AUC0-∞)
研究概览
简要总结
Relative bioavailability of BI 10773 given alone and together with verapamil
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 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
Reference
single dose BI 10773
干预措施: BI 10773 (Drug)
Test
single dose BI 10773 + single dose verapamil
干预措施: Verapamil (Drug)
Test
single dose BI 10773 + single dose verapamil
干预措施: BI 10773 (Drug)
结局指标
主要结局
Area Under the Curve 0 to Infinity (AUC0-∞)
时间窗: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration
Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity.
Maximum Measured Concentration (Cmax)
时间窗: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration
Maximum measured concentration of empagliflozin (empa) in plasma.
次要结局
- Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)(0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration)
- Time From 0 to Maximum Plasma Concentration (Tmax)(0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration)
- Terminal Elimination Rate Constant (λz)(0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration)
- Terminal Half-life in Plasma (t1/2)(0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration)
- Mean Residence Time in the Body After Administration (MRTpo)(0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration)
- Apparent Clearance in Plasma After Extravascular Administration (CL/F)(0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration)
- Apparent Volume of Distribution Following an Extravascular Dose (Vz/F)(0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration)
- Clinically Relevant Abnormalities for Physical Examination, Vital Signs, Blood Chemistry and Electrocardiogram (ECG).(Day1 to Day 11)
- Assessment of Tolerability by Investigator(Within Day 15 to Day 25)