Bioequivalence of a Fixed Dose Combination Tablet of Linagliptin/Metformin Extended Release (2.5 mg/1000 mg) Compared With the Free Combination of Linagliptin and Metformin Extended Release Tablets in Healthy Subjects (an Open-label, Randomised, Single Dose, Two-way Crossover Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)
研究概览
简要总结
The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing linagliptin and metformin extended release compared to the free combination of linagliptin and metformin extended release.
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
Single tablets first, fed
single tablets of linagliptin and metformin followed by Linagliptin/Metformin FDC, fed
干预措施: Metformin (Drug)
FDC first, fasted
Linagliptin/Metformin FDC followed by single tablets of linagliptin and metformin, fasted
干预措施: Linagliptin (Drug)
FDC first, fasted
Linagliptin/Metformin FDC followed by single tablets of linagliptin and metformin, fasted
干预措施: Metformin (Drug)
FDC first, fasted
Linagliptin/Metformin FDC followed by single tablets of linagliptin and metformin, fasted
干预措施: Linagliptin/Metformin FDC (Drug)
Single tablets first, fasted
single tablets of linagliptin and metformin followed by Linagliptin/Metformin FDC, fasted
干预措施: Linagliptin (Drug)
Single tablets first, fasted
single tablets of linagliptin and metformin followed by Linagliptin/Metformin FDC, fasted
干预措施: Metformin (Drug)
Single tablets first, fasted
single tablets of linagliptin and metformin followed by Linagliptin/Metformin FDC, fasted
干预措施: Linagliptin/Metformin FDC (Drug)
FDC first, fed
Linagliptin/Metformin FDC followed by single tablets of linagliptin and metformin, fed
干预措施: Linagliptin (Drug)
FDC first, fed
Linagliptin/Metformin FDC followed by single tablets of linagliptin and metformin, fed
干预措施: Metformin (Drug)
FDC first, fed
Linagliptin/Metformin FDC followed by single tablets of linagliptin and metformin, fed
干预措施: Linagliptin/Metformin FDC (Drug)
Single tablets first, fed
single tablets of linagliptin and metformin followed by Linagliptin/Metformin FDC, fed
干预措施: Linagliptin (Drug)
Single tablets first, fed
single tablets of linagliptin and metformin followed by Linagliptin/Metformin FDC, fed
干预措施: Linagliptin/Metformin FDC (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)
时间窗: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration
AUC 0-72 (area under the concentration-time curve of Linagliptin in plasma from 0 to 72 hours) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Maximum Measured Concentration of Linagliptin in Plasma (Cmax)
时间窗: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration
Cmax (maximum measured concentration of Linagliptin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
时间窗: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration
AUC 0-tz (Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Cmax of Metformin in Plasma
时间窗: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration
Cmax (maximum measured concentration of Metformin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
次要结局
- Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)(1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration)
- AUC0-inf of Metformin in Plasma(1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration)