Bioequivalence of Empagliflozin/Metformin (500 mg) Fixed Dose Combination Tablets Compared to Single Tablets Administered Together in Healthy Male and Female Volunteers Under Fed Conditions (an Open-label, Randomised, Single-dose, Four-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
- AUC0-∞ for Empagliflozin
研究概览
简要总结
The primary objective of this trial is to establish bioequivalence of two fixed dose combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin [Test 1] and low dose empagliflozin/500 mg metformin [Test 2]) and of the single tablets (medium dose empagliflozin tablets + Glucophage® 500 mg tablet [Reference 1] and low dose empagliflozin tablet + Glucophage® 500 mg tablet [Reference 2]) when administered together after a high fat, high caloric meal.
The assessment of safety and tolerability will be an additional objective of this trial.
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
FDC empagliflozin dose 1 and metformin
fix dose combination tablet after intake of a high fat, high caloric meal
干预措施: empagliflozin and metformin (Drug)
empagliflozin dose 1 + metformin tablets
single tablets after intake of a high fat, high caloric meal
干预措施: empagliflozin (Drug)
empagliflozin dose 1 + metformin tablets
single tablets after intake of a high fat, high caloric meal
干预措施: metformin (Glucophage®) (Drug)
FDC empagliflozin dose 2 and metformin
fix dose combination tablet after intake of a high fat, high caloric meal
干预措施: empagliflozin and metformin (Drug)
empagliflozin dose 2 + metformin tablets
single tablets after intake of a high fat, high caloric meal
干预措施: metformin (Glucophage®) (Drug)
empagliflozin dose 2 + metformin tablets
single tablets after intake of a high fat, high caloric meal
干预措施: empagliflozin (Drug)
结局指标
主要结局
AUC0-∞ for Empagliflozin
时间窗: 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Empagliflozin
AUC0-∞ for Metformin
时间窗: 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Metformin
Cmax for Empagliflozin
时间窗: 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake
Cmax (maximum measured concentration of the analyte in plasma) for Empagliflozin
Cmax for Metformin
时间窗: 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake
Cmax (maximum measured concentration of the analyte in plasma) for Metformin
次要结局
- AUC0-tz for Empagliflozin(1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake)
- AUC0-tz for Metformin(1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake)