A Two Part Bioequivalence Study to Compare Two Fixed Dose Combination (FDC) Tablets of Dapagliflozin/Metformin XR 5/500 mg (Part 1) and 10/1000 mg (Part 2) Manufactured at Two Different Plants (Humacao, Puerto Rico and Mount Vernon, US) in Healthy Subjects Under Fasting and Fed Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- Part 1 - Area under the plasma concentration versus time curve (AUC) for each analyte and each state
研究概览
简要总结
This is a bioequivalence study of two doses of the dapagliflozin/metformin XR tablet manufactured at two different plants.
详细描述
This is a two part, open-label, randomized, 4-period, 4-treatment (per study part) crossover study in healthy subjects (males and females of non-childbearing potential), performed at a single study center, conducted to establish the bioequivalence of 2 strengths of dapagliflozin/metformin XR tablets manufactured at two different plants.
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
Treatment A
Dapagliflozin/metformin XR 5/500 Mount Vernon Test Product Fed
干预措施: Dapagliflozin/metformin XR 5/500mg (Drug)
Treatment B
Dapagliflozin/metformin XR 5/500 Humacao Reference Product Fed
干预措施: Dapagliflozin/metformin XR 5/500 mg (Drug)
Treatment C
Dapagliflozin/metformin XR 5/500 Mount Vernon Test Product Fasted
干预措施: Dapagliflozin/metformin XR 5/500mg (Drug)
Treatment D
Dapagliflozin/metformin XR 5/500 Humacao Reference Product Fasted
干预措施: Dapagliflozin/metformin XR 5/500mg (Drug)
Treatment E
Dapagliflozin/metformin XR 10/1000 Mount Vernon Test Product Fed
干预措施: Dapagliflozin/metformin XR 10/1000mg (Drug)
Treatment F
Dapagliflozin/metformin XR 10/1000 Humacao Reference Product Fed
干预措施: Dapagliflozin/metformin XR 10/1000mg (Drug)
Treatment G
Dapagliflozin/metformin XR 10/1000 Mount Vernon Test Product Fasted
干预措施: Dapagliflozin/metformin XR 10/1000mg (Drug)
Treatment H
Dapagliflozin/metformin XR 10/1000 Humacao Reference Product Fasted
干预措施: Dapagliflozin/metformin XR 10/1000mg (Drug)
结局指标
主要结局
Part 1 - Area under the plasma concentration versus time curve (AUC) for each analyte and each state
时间窗: Based on pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose sampling times
To demonstrate the bioequivalence of dapagliflozin/metformin XR 5/500 mg manufactured at Mount Vernon plant and dapagliflozin/metformin XR 5/500 mg manufactured at Humacao plant in metformin and in dapagliflozin plasma concentrations for the fed state and, separately, the fasted state.
Part 2 - Area under the plasma concentration versus time curve (AUC) for each analyte and each state
时间窗: Based on pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose sampling times
To demonstrate the bioequivalence of dapagliflozin/metformin XR 10/1000 mg manufactured at Mount Vernon plant and dapagliflozin/metformin XR 10/1000 mg manufactured at Humacao plant in metformin and dapagliflozin plasma concentrations for the fed state and, separately, the fasted state.
Part 1 - Peak Plasma Concentration (Cmax) for each analyte and each state
时间窗: Based on pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose sampling times
To demonstrate the bioequivalence of dapagliflozin/metformin XR 5/500 mg manufactured at Mount Vernon plant and dapagliflozin/metformin XR 5/500 mg manufactured at Humacao plant in metformin and in dapagliflozin plasma concentrations for the fed state and, separately, the fasted state.
Part 2 - Peak Plasma Concentration (Cmax) for each analyte and each state
时间窗: Based on pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose sampling times
To demonstrate the bioequivalence of dapagliflozin/metformin XR 10/1000 mg manufactured at Mount Vernon plant and dapagliflozin/metformin XR 10/1000 mg manufactured at Humacao plant in metformin and in dapagliflozin plasma concentrations for the fed state and, separately, the fasted state.
次要结局
- Time to reach maximum plasma concentration (tmax)(Based on pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose sampling times)
- Apparent total body clearance after extravascular administration (CL/F)(Based on pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose sampling times)
- Laboratory assessments - hematology(10,5 weeks)
- Area under plasma concentration - time curve from time zero to infinity (AUC)(Based on pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose sampling times)
- Blood pressure(10,5 weeks)
- Electrocardiogram (ECG)(10,5 weeks)
- Terminal elimination rate constant (λz)(Based on pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose sampling times)
- Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)(Based on pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose sampling times)
- Adverse events(10,5 weeks)
- Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz)(Based on pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose sampling times)
- Heart rate(10,5 weeks)
- Laboratory assessments - clinical chemistry(10,5 weeks)
- Laboratory assessments - urinalysis(10,5 weeks)