NCT01002807已完成1 期
Bioavailability Study of Two Prototype Fixed Dose Combination (FDC) Formulations of 10 mg Dapagliflozin and 1000 mg Metformin Extended Release (XR) Tablet Relative to Dapagliflozin 10 mg Tablet and Glucophage® XR 2 X 500 mg Tablets Coadministered to Healthy Subjects in a Fasted State
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Blood samples to measure the pharmacokinetic parameters Cmax and AUC for the combination products versus each investigational product alone
研究概览
简要总结
To assess the relative bioavailability of dapagliflozin and metformin from the two FDC formulations, comprised of 10 mg dapagliflozin and 1000 mg metformin XR, relative to coadministration of a dapagliflozin 10 mg tablet and 2 x 500 mg Glucophage® XR tablets, in healthy subjects in a fasted state.
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
- •Men and women ages 18 to 45 inclusive
- •Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- •Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/ [height (m)]2
排除标准
- •WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
- •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
- •Glucosuria at screening
- •Abnormal liver functions tests (ALT, AST or total bilirubin > 10% above ULN)
- •Presence of edema on physical exam
- •History of diabetes mellitus
- •History of heart failure
- •History of renal insufficiency
- •History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months
- •History of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections
- •Estimated creatinine clearance (ClCR) of < 80 mL/min using the Cockcroft Gault formula
- •History of allergy or intolerance to metformin or other similar agents
研究组 & 干预措施
FDC of dapagliflozin/metformin XR
Other
干预措施: Dapagliflozin (Drug)
FDC of dapagliflozin/metformin XR
Other
干预措施: Metformin XR (Drug)
FDC of dapagliflozin/reduced mass metformin XR
Other
干预措施: Dapagliflozin (Drug)
FDC of dapagliflozin/reduced mass metformin XR
Other
干预措施: Metformin XR (Drug)
dapagliflozin and Glucophage® XR
Other
干预措施: Dapagliflozin (Drug)
dapagliflozin and Glucophage® XR
Other
干预措施: Glucophage (Drug)
结局指标
主要结局
Blood samples to measure the pharmacokinetic parameters Cmax and AUC for the combination products versus each investigational product alone
时间窗: 48 hours post-dose
次要结局
- Safety and tolerability measures (adverse events, physical exams, vital signs, ECGs, and clinical laboratory assessments)(15 timepoints in 48 hours time interval)
研究者
研究点 (1)
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