Relative Bioavailability of Two Newly Developed Extended Release FDC Tablet Strengths (5mg/1000mg and 2.5 mg/750 mg) of Linagliptin/Metformin Extended Release Compared With the Free Combination of Linagliptin 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
- Cmax of Metformin
研究概览
简要总结
The purpose of the trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing linagliptin & metformin and the single tablets of linagliptin and metformin 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
5 mg Linagliptin/1500 mg Metformin
4 single tablets under fasted conditions
干预措施: 3x500 mg Metformin (Glumetza) (Drug)
5 mg Linagliptin/1500 mg Metformin FDC
2 FDC tablets under fasted conditions
干预措施: 2 x 2.5 mg Linagliptin/750 mg Metformin FDC (Drug)
5 mg Linagliptin/1000 mg Metformin, fed
3 single tablets under fed conditions
干预措施: 2x500 mg Metformin (Glumetza) (Drug)
5 mg Linagliptin/1000 mg Metformin, fed
3 single tablets under fed conditions
干预措施: 5 mg Linagliptin (Tradjenta) (Drug)
5 mg Linagliptin/1500 mg Metformin
4 single tablets under fasted conditions
干预措施: 5 mg Linagliptin (Tradjenta) (Drug)
5 mg Linagliptin/1000 mg Metformin FDC
1 fixed dose combination(FDC) tablet under fasted conditions
干预措施: 5 mg Linagliptin/1000mg Metformin FDC (Drug)
5 mg Linagliptin/1000 mg Metformin
3 single tablets under fasted conditions
干预措施: 5 mg Linagliptin (Tradjenta) (Drug)
5 mg Linagliptin/1000 mg Metformin
3 single tablets under fasted conditions
干预措施: 2 x 500 mg Metformin (Glumetza) (Drug)
5mg Linagliptin/1000mg Metformin, FDCfed
1 FDC tablet under fed conditions
干预措施: 5 mg Linagliptin/1000 mg Metformin FDC (Drug)
结局指标
主要结局
Cmax of Metformin
时间窗: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period
Maximum Measured Concentration (Cmax) of Metformin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
AUC0-72 of Linagliptin
时间窗: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period
Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
Cmax of Linagliptin
时间窗: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period
Maximum Measured Concentration (Cmax) of Linagliptin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
AUC0-tz of Metformin
时间窗: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period
Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
次要结局
- AUC0-infinity of Linagliptin(1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period)
- AUC0-infinity of Metformin(1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period)