A Two Part, Open Label, Randomized, Phase I Bioequivalence Study Comparing the Fixed Dose Combination Dapagliflozin/Metformin IR Tablet (2.5 mg/850 mg or 5 mg/1000 mg) vs. the Free Combination of Dapagliflozin and Metformin IR Tablets, in Healthy Volunteers, in the Fed State
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- bioequivalence will be demonstrated if the 90% confidence interval (CI) for the formulation effect is contained within the interval of 0.8000-1.2500 for AUC(0-t), AUCinf and Cmax with respect to both dapagliflozin and metformin.
研究概览
简要总结
The primary objective of the study is to establish if the same amount of drug is absorbed into the blood after ingesting a combination dapagliflozin/metformin tablet vs. the individual dapagliflozin tablet and individual metformin tablet.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female healthy volunteers must be post-menopausal (cessation of menses >1year), be surgically sterile (documented) or hysterectomy or on abstinence
- •Have normal physical exam, vital signs Electrocardiogram (ECG) findings, and laboratory values
排除标准
- •Use of prescription medication for a chronic or acute medical condition within 3 weeks of randomization
- •History of allergy to metformin
- •Previous participation in an AstraZeneca (AZ) or BristolMyers-Sqibb dapagliflozin study
研究组 & 干预措施
1
Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet
干预措施: Dapagliflozin/Metformin (Drug)
1
Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet
干预措施: Dapagliflozin (Drug)
1
Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet
干预措施: Metformin (Drug)
2
Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets
干预措施: Dapagliflozin/Metformin (Drug)
2
Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets
干预措施: Dapagliflozin (Drug)
2
Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets
干预措施: Metformin (Drug)
3
Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet
干预措施: Dapagliflozin/Metformin (Drug)
3
Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet
干预措施: Dapagliflozin (Drug)
3
Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet
干预措施: Metformin (Drug)
4
Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets
干预措施: Dapagliflozin/Metformin (Drug)
4
Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets
干预措施: Dapagliflozin (Drug)
4
Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets
干预措施: Metformin (Drug)
结局指标
主要结局
bioequivalence will be demonstrated if the 90% confidence interval (CI) for the formulation effect is contained within the interval of 0.8000-1.2500 for AUC(0-t), AUCinf and Cmax with respect to both dapagliflozin and metformin.
时间窗: Immediately prior to administration of the investigational product (IP). After intake of IP PK blood samples will be drawn every 15 minutes for the first hour, every 30 minutes for the second hour and every hour up to 72 h after intake of IP.
次要结局
- To examine the safety and tolerability of the combination of dapagliflozin and metformin.(Throughout study (for 4 days in each period and a follow-up visit ~6 days later))