Relative Bioavailability of Single Dose BI 10773 Co-administered With Multiple Doses of 600 mg Gemfibrozil Bid Compared to Single Dose Treatment of BI 10773 Alone in Healthy Volunteers - a Phase I, Open-label, Randomised, 2-way Crossover Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞)
研究概览
简要总结
To investigate the relative bioavailability of BI 10773 following coadministration with 600 mg gemfibrozil bid dosed to steady-state in comparison to BI 10773 when given alone.
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
BI 10773
Subject to receive one single dose BI 10773
干预措施: BI 10773 (Drug)
BI 10773
Subject to receive one single dose BI 10773
干预措施: Gemfibrozil (Drug)
BI 10773 plus gemfibrozil
Subject to receive one single dose BI 10773 plus 600 mg gemfibrozil bid for 5 days
干预措施: BI 10773 (Drug)
结局指标
主要结局
Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞)
时间窗: 0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose
Area under the plasma concentration-time curve of the analyte from time 0 extrapolated to infinity. The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV).
Total Empa: Maximum Measured Concentration (Cmax)
时间窗: 0 minutes (min), 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose
Maximum measured concentration of total Empagliflozin (Empa) in plasma, per period. The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV).
次要结局
- Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)(0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose)