Bioequivalence Study of the Fixed Dose Combination of 2.5 mg Saxagliptin and 500 mg Metformin Tablet Relative to a 2.5 mg Saxagliptin (Onglyza) Tablet and a 500 mg Metformin (Glucophage Marketed in Canada by Sanofi-Aventis) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Observed Maximum Plasma Concentration (Cmax) of Saxagliptin, Tablets and Fixed-dose Combination (FDC), Administered to Participants in the Fasted and Fed States
研究概览
简要总结
To demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin (Glucophage, marketed in Canada by Sanofi-Aventis) tablets coadministered to healthy participants in the fasted and fed states.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women, aged 18 to 55 years, inclusive
- •Healthy participants as determined by a lack of clinically significant deviation from normal in medical history, physical examination, electrocardiograms, and clinical laboratory determinations
- •Body Mass Index of 18 to 32 kg/m^2, inclusive
排除标准
- •Any significant acute or chronic medical illness
- •Current or recent (within 3 months) gastrointestinal disease
- •Any major surgery within 4 weeks of study drug administration
- •History of allergy to DPP-4 inhibitors or related compounds
- •History of allergy or intolerance to metformin or other similar acting agents
- •Previous exposure to saxagliptin
- •Exposure to metformin within 3 months pervious to study drug administration
- •Estimated creatinine clearance of <80 mL/min using the Cockcroft Gault formula
研究组 & 干预措施
Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)
Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fasted state
干预措施: Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state) (Drug)
Saxagliptin, 2.5 mg/Metformin, 500 mg FDC (fasted state)
Single oral dose of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet administered in the fasted state
干预措施: Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state) (Drug)
Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)
Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fed state
干预措施: Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state) (Drug)
Saxagliptin, 2.5 mg/Metformin, 500 mg FDC (fed state)
Single oral dose of saxagliptin, 2.5 mg/metformin, 500 mg, FDC tablet administered in the fed state
干预措施: Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state) (Drug)
结局指标
主要结局
Observed Maximum Plasma Concentration (Cmax) of Saxagliptin, Tablets and Fixed-dose Combination (FDC), Administered to Participants in the Fasted and Fed States
时间窗: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
Observed Cmax of Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
时间窗: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
Terminal Half-life (t1/2) of Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
时间窗: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC[0-t]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States
时间窗: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
AUC[0-t] for Metformin, Tablets and FDC, Given in the Fasted and Fed States
时间窗: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
AUC From Time 0 Extrapolated to Infinity (AUC[0-inf]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States
时间窗: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
AUC[0-inf] for Metformin, Tablets and FDC, Administered in the Fasted and Fed States
时间窗: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
Time to Achieve the Observed Maximum Plasma Concentration (Tmax) for Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
时间窗: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
次要结局
- Number of Participants With Death as Outcome, Serious Adverse Events, and Adverse Events (AEs) Leading to Discontinuation(Continuously over Days 1 to 3 of treatment Periods 1, 2, 3, and 4)
- Number of Participants With Clinically Significant Abnormalities in Hematology, Serum Chemistry, and Urinalysis Laboratory Test Results(At screening visit, at Day -1 of Periods 1 through 4, and at discharge)
- Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Results(At screening visit, Day -1 of Period 1, and at study discharge)
- Number of Participants With Clinically Significant Abnormalities in Body Temperature, Blood Pressure, or Heart Rate(At screening visit, prior to dosing on Day 1 of Periods 1 through 4, and at study discharge.)