An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on Fixed Dose Combination Dapagliflozin/Metformin Tablet (5 mg/1000 mg) in Healthy Male and Female Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- To assess the effect of food on the pharmacokinetics of dapagliflozin and metformin.
研究概览
简要总结
The purpose of this study is to determine whether treatment with a fixed dose combination dapagliflozin/metformin tablet is affected by food.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •BMI 18-30 kg/m2
排除标准
- •History of clinically significant illness.
- •History of alcohol or drug abuse
研究组 & 干预措施
1
Dapagliflozin/metformin tablet, high fat, high calorie breakfast day 1, visit 2, 7-14 days wash-out, Dapagliflozin/metformin tablet, fasting conditions day 1, visit 3.
干预措施: Dapagliflozin/Metformin (Drug)
2
Dapagliflozin/metformin tablet, fasting conditions day 1, visit 2, 7-14 days wash-out, Dapagliflozin/metformin tablet, high fat, high calorie breakfast day 1, visit 3.
干预措施: Dapagliflozin/Metformin (Drug)
结局指标
主要结局
To assess the effect of food on the pharmacokinetics of dapagliflozin and metformin.
时间窗: Serial PK sampling will be done on Days 1-4 at visit 2 and 3.
primary - single dose Cmax, AUCinf, AUC(0-t) of dapagliflozin and metformin.. secondary - single dose tmax, t1/2 of dapagliflozin and metformin
次要结局
- To examine the safety and tolerability of the fixed-dose combination tablet of dapagliflozin and metformin.(ECG at screening and follow-up. BP/pulse at screening, once daily during residential period and at follow-up. Clinical chemistry, haematology, and urine analyses at screening, day-1, day 4, and at follow-up.)