Relative Bioavailability of 25 mg BI 10773 (Final Formulation) Compared to 25 mg BI 10773 XX (Trial Formulation 2) Following Oral Administration in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum Measured Concentration (Cmax)
研究概览
简要总结
The objective of the study is to investigate the relative bioavailability of the final tablet formulation (FF) of BI 10773 in comparison to the tablet formulation 2 (TF2).
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 Final Formulation
one single film-coated tablet in the morning
干预措施: BI 10773 (Final Formulation) (Drug)
BI 10773 XX Trial Formulation 2
one single dose tablet in the morning
干预措施: BI 10773 XX (Trial Formulation 2) (Drug)
结局指标
主要结局
Maximum Measured Concentration (Cmax)
时间窗: 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Maximum measured concentration of empagliflozin (empa) in plasma. Note the standard deviation is actually the CV (%).
Area Under the Curve 0 to Infinity (AUC0-∞)
时间窗: 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 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. Note the standard deviation is actually the coefficient of variation (CV (%)).
次要结局
- Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)(30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration)