Bioequivalence of Empagliflozin/Metformin Fixed Dose Combination Tablets Compared to Single Tablets Administered Together in Healthy Male and Female Volunteers Under Fed and Fasted Conditions (an Open-label, Randomised, Single-dose, Crossover Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Empagliflozin
研究概览
简要总结
Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and bioequivalence of empagliflozin/metformin (FDC) tablet compared with single tablets empagliflozin and metformin under fed conditions (Part II).
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
1 Empagliflozin/Metformin (T)
fixed-dose-combination tablet, oral with 240 ml water under fasted conditions
干预措施: Empagliflozin/Metformin (Drug)
2 Empagliflozin/Metformin (T)
fixed-dose-combination tablet, oral with 240 ml water under fed conditions
干预措施: Empagliflozin/Metformin (Drug)
3 Empagliflozin + Metformin (R)
tablets, oral with 240 ml water under fasted conditions
干预措施: Empagliflozin (Drug)
3 Empagliflozin + Metformin (R)
tablets, oral with 240 ml water under fasted conditions
干预措施: Metformin (Drug)
4 Empagliflozin + Metformin (R)
tablets, oral with 240 ml water under fed conditions
干预措施: Empagliflozin (Drug)
4 Empagliflozin + Metformin (R)
tablets, oral with 240 ml water under fed conditions
干预措施: Metformin (Drug)
5 Empagliflozin/Metformin (T)
fixed-dose-combination tablet, oral with 240 ml water under fed conditions
干预措施: Empagliflozin/Metformin (Drug)
6 Empagliflozin + Metformin (R)
tablets, oral with 240 ml water under fed conditions
干预措施: Empagliflozin (Drug)
6 Empagliflozin + Metformin (R)
tablets, oral with 240 ml water under fed conditions
干预措施: Metformin (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Empagliflozin
时间窗: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Empagliflozin
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Metformin
时间窗: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Metformin
Maximum Measured Concentration of the Analyte in Plasma, Empagliflozin
时间窗: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Cmax: maximum measured concentration of the analyte in plasma for Empagliflozin
Maximum Measured Concentration of the Analyte in Plasma, Metformin
时间窗: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Cmax: maximum measured concentration of the analyte in plasma for Metformin
次要结局
- Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Empagliflozin(1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration)
- Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Metformin(1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration)