Bioequivalence Study of the Fixed Dosed Combination of 5 mg Saxagliptin and 1000 mg Metformin Extended Release Tablet Manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico Relative to the Fixed Dosed Combination Tablet Manufactured in Mt. Vernon, Indiana and Bioequivalence Study of the Fixed Dosed Combination of 5 mg Saxagliptin and 500 mg Metformin Extended Release Tablet Manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico Relative to the Fixed Dosed Combination Tablet Manufactured in Mt. Vernon, Indiana Administered to Healthy Subjects Under Fed Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Point estimates and 90% CIs for the ratio of geometric means for Cmax for Saxagliptin and Metformin in the 5/1000 mg FDC XR (Mt.Vernon/Humacao) and 5/1000 mg FDC XR (Mt. Vernon)
研究概览
简要总结
The purpose of this study is to determine if tablets manufactured at different sites have the same bioavailability, that is yield similar blood levels/concentrations of the drugs and are handled by the body similarly
详细描述
Primary Purpose:
Other: Protocol designed to demonstrate the bioequivalence of the fixed dose combination of 5 mg Saxagliptin and 1000 mg Metformin Extended Release Tablet manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico relative to the fixed dose combination tablet manufactured in Mt. Vernon, Indiana and the bioequivalence of the fixed dose combination of 5 mg Saxagliptin and 500 mg Metformin Extended Release Tablet manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico relative to the fixed dose combination tablet manufactured in Mt. Vernon, Indiana in healthy human subjects under fed conditions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects, 18-45 years of age
- •Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive
- •Women must have a negative serum or urine pregnancy test within 24 hours prior to the start of investigational product
排除标准
- •Any significant acute or chronic medical illness
- •Estimated creatinine clearance of <60 mL/min as calculated using the Modification of Diet in Renal Disease method Current or recent (within 3 months of study drug administration)
- •Gastrointestinal (GI) disease that could affect the absorption of study drug
- •Inability to tolerate oral medication
- •History of allergies or adverse reactions to DPP4 inhibitors or Metformin or related compounds
- •Current smoker or recent (within 6 months of study drug administration) history of regular tobacco use (positive cotinine test)
研究组 & 干预措施
Arm A: Saxagliptin/Metformin XR FDC (Mt. Vernon/Humacao)
Saxagliptin 5 mg /Metformin 1000 mg (Mt. Vernon/Humacao) tablet by mouth once daily on Day 1 of Periods 1 and 2
干预措施: Saxagliptin/Metformin (Drug)
Arm B: Saxagliptin/Metformin XR FDC (Mt. Vernon)
Saxagliptin 5 mg/Metformin 1000 mg (Mt. Vernon) tablet by mouth once daily on Day 1 of Periods 1 and 2
干预措施: Saxagliptin/Metformin (Drug)
Arm C: Saxagliptin/Metformin XR FDC (Mt. Vernon/Humacao)
Saxagliptin 5 mg/Metformin 500 mg (Mt. Vernon/Humacao) tablet by mouth once daily on Day1 of Periods 1 and 2
干预措施: Saxagliptin/Metformin (Drug)
Arm D: Saxagliptin/Metformin XR FDC (Mt. Vernon)
Saxagliptin 5 mg/Metformin 500 mg (Mt. Vernon) tablet by mouth once daily Day 1 of Periods 1 and 2
干预措施: Saxagliptin/Metformin (Drug)
结局指标
主要结局
Point estimates and 90% CIs for the ratio of geometric means for Cmax for Saxagliptin and Metformin in the 5/1000 mg FDC XR (Mt.Vernon/Humacao) and 5/1000 mg FDC XR (Mt. Vernon)
时间窗: 19 time points up to Day 3 of Periods 1 and 2
Cmax=Maximum observed plasma concentration CI=Confidence interval FDC=Fixed dosed combination XR=Extended release
Point estimates and 90% CIs for the ratio of geometric means for AUC(0-T) for Saxagliptin and Metformin in the 5/1000 mg FDC XR (Mt.Vernon/Humacao) and 5/1000 mg FDC XR (Mt. Vernon)
时间窗: 19 time points up to Day 3 of Periods 1 and 2
AUC(0-T)=Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration
Point estimates and 90% CIs for the ratio of geometric means for AUC(INF) for Saxagliptin and Metformin in the 5/1000 mg FDC XR (Mt.Vernon/Humacao) and 5/1000 mg FDC XR (Mt. Vernon)
时间窗: 19 time points up to Day 3 of Periods 1 and 2
AUC(INF)=Area under the plasma concentration-time curve from time zero extrapolated to infinity
Point estimates and 90% CIs for the ratio of geometric means for Cmax for Saxagliptin and Metformin in the 5/500 mg FDC XR (Mt. Vernon/Humacao) and 5/500 mg FDC XR (Mt. Vernon)
时间窗: 19 time points up to Day 3 of Periods 1 and 2
Point estimates and 90% CIs for the ratio of geometric means for AUC(0-T) for Saxagliptin and Metformin in the 5/500 mg FDC XR (Mt. Vernon/Humacao) and 5/500 mg FDC XR (Mt. Vernon)
时间窗: 19 time points up to Day 3 of Periods 1 and 2
Point estimates and 90% CIs for the ratio of geometric means for AUC(INF) for Saxagliptin and Metformin in the 5/500 mg FDC XR (Mt. Vernon/Humacao) and 5/500 mg FDC XR (Mt. Vernon)
时间窗: 19 time points up to Day 3 of Periods 1 and 2
次要结局
- Time to maximum observed plasma concentration (Tmax) for Saxagliptin and Metformin and for 5-OH Saxagliptin (Treatments A, B, C, and D)(19 time points up to Day 3 of Periods 1 and 2)
- Terminal half life (T-HALF) for Saxagliptin and Metformin and for 5-OH Saxagliptin (Treatments A, B, C, and D)(19 time points up to Day 3 of Periods 1 and 2)
- Cmax for 5-OH Saxagliptin (Treatments A, B, C, and D)(19 time points up to Day 3 of Periods 1 and 2)
- AUC(0-T) for 5-OH Saxagliptin (Treatments A, B, C, and D)(19 time points up to Day 3 of Periods 1 and 2)
- AUC(INF) for 5-OH Saxagliptin (Treatments A, B, C, and D)(19 time points up to Day 3 of Periods 1 and 2)
- Safety assessments based on adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests(Up to Day 3 of Periods 1 and 2 and up to 30 days post discontinuation of dosing)