Relative Bioavailability of Two Newly Developed FDC Tablet Strengths (10 mg/1000 mg and 5mg/750mg) of Empagliflozin/Metformin Extended Release Compared With the Free Combination of Empagliflozin and Metformin Extended Release in Healthy Subjects (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
- 72
- 试验地点
- 1
- 主要终点
- AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point), for Empagliflozin
研究概览
简要总结
The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combinations (FDC) tablets containing empagliflozin & metformin XR and the single tablets of empagliflozin and metformin XR when administered singularly
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
High dose, fasted
1 fixed dose combination (FDC) tablet vs 3 single tablets under fasted conditions
干预措施: 10 mg Empagliflozin/1000 mg Metformin XR (Drug)
High dose, fasted
1 fixed dose combination (FDC) tablet vs 3 single tablets under fasted conditions
干预措施: 1 tablet Empagliflozin/2 tablets Metformin XR (Drug)
High dose, fed
1 fixed dose combination (FDC) tablet vs 3 single tablets under fed conditions
干预措施: 1 tablet Empagliflozin/2 tablets Metformin XR (Drug)
High dose, fed
1 fixed dose combination (FDC) tablet vs 3 single tablets under fed conditions
干预措施: 10 mg Empagliflozin/1000 mg Metformin XR (Drug)
Low dose, fasted
2 fixed dose combination (FDC) tablets vs 4 single tablets under fasted conditions
干预措施: 1 tablet 10 mg Empagliflozin/3 tablets Metformin XR (Drug)
Low dose, fasted
2 fixed dose combination (FDC) tablets vs 4 single tablets under fasted conditions
干预措施: 2 tablets 5 mg Empagliflozin/750 Metformin XR (Drug)
结局指标
主要结局
AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point), for Empagliflozin
时间窗: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) for Metformin
时间窗: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point
Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Empagliflozin
时间窗: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Maximum measured concentration of empagliflozin in plasma (Cmax).
Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Metformin
时间窗: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Maximum measured concentration of metformin in plasma
次要结局
- AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Empagliflozin(1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration)
- AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Metformin(1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration)