A Randomised, Open-label, Three-way Crossover Trial to Investigate the Effect of Rifampicin and Probenecid on Empagliflozin Pharmacokinetics in Healthy Male and Female 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
- Total Empa: Maximum Measured Concentration (Cmax)
研究概览
简要总结
The objectives of the trial are to investigate the effect of concurrent administration of rifampicin and probenecid on the pharmacokinetics of empagliflozin.
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
A (Reference)
Empagliflozin (BI 10773), Film-coated tablet, single dose
干预措施: Probenecid (Drug)
A (Reference)
Empagliflozin (BI 10773), Film-coated tablet, single dose
干预措施: Empagliflozin (Drug)
A (Reference)
Empagliflozin (BI 10773), Film-coated tablet, single dose
干预措施: Rifampicin (Drug)
B (Test 1)
Empagliflozin (BI 10773), Film-coated tablet, single dose, and Rifampicin,Film-coated tablet single dose
干预措施: Rifampicin (Drug)
B (Test 1)
Empagliflozin (BI 10773), Film-coated tablet, single dose, and Rifampicin,Film-coated tablet single dose
干预措施: Empagliflozin (Drug)
C (Test 2)
Empagliflozin (BI 10773), Film-coated tablet, single dose, and Probenecid Tablet twice daily
干预措施: Probenecid (Drug)
C (Test 2)
Empagliflozin (BI 10773), Film-coated tablet, single dose, and Probenecid Tablet twice daily
干预措施: Empagliflozin (BI 10773) (Drug)
结局指标
主要结局
Total Empa: Maximum Measured Concentration (Cmax)
时间窗: 15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose
Maximum measured concentration of total empa in plasma, per period.
Total Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞)
时间窗: 15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose
Area under the concentration-time curve of total empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.
次要结局
- Total Empagliflozin: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)(15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose)