Relative Bioavailability of BI 10773 and Simvastatin After Single and Combined Administration - 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
- 18
- 试验地点
- 1
- 主要终点
- Simvastatin: Area Under the Curve 0 to Infinity (AUC0-∞)
研究概览
简要总结
The objective of the study is to investigate the drug-drug interaction potential between BI 10773 and simvastatin.
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
treatment A, reference
1 tablet BI 10773, oral administration with 240 ml water
干预措施: BI 10773 (Drug)
treatment B, reference
1 tablet simvastatin, oral administration with 240 ml water
干预措施: simvastatin (Drug)
treatment C, test
1 tablet BI 10773 + 1 tablet simvastatin, oral administration with 240 ml water
干预措施: BI 10773 (Drug)
treatment C, test
1 tablet BI 10773 + 1 tablet simvastatin, oral administration with 240 ml water
干预措施: simvastatin (Drug)
结局指标
主要结局
Simvastatin: Area Under the Curve 0 to Infinity (AUC0-∞)
时间窗: 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. Simvastatin acid is an active metabolite of simvastatin. The geometric mean (gMean) and geometric coefficient of variation (gCV) are adjusted values.
Empa: Area Under the Curve 0 to Infinity (AUC0-∞)
时间窗: 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity. The geometric mean (gMean) and geometric coefficient of variation (gCV) are adjusted values.
Empa: Maximum Measured Concentration (Cmax)
时间窗: 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Maximum measured concentration of the analyte in plasma, per period. The geometric mean and geometric coefficient of variation (gCV) are adjusted values
Simvastatin: Maximum Measured Concentration (Cmax)
时间窗: 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Maximum measured concentration of the analyte in plasma, per period. The geometric mean and geometric coefficient of variation (gCV) are adjusted values.
次要结局
- Simvastatin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)(0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration)
- Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)(0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration)