NCT00562250已完成1 期
Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects
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
- 11
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration and exposure to glimepiride and dapagliflozin when administered alone and administered together
研究概览
简要总结
The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and tolerability of dapagliflozin with be assessed alone and while taking glimepiride
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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 subjects with BMI of 18-32 kg/m2
排除标准
- •Abnormal physical or lab findings
- •Allergies to any sulfonylurea or related compounds
研究组 & 干预措施
Arm 1
Experimental
干预措施: Dapagliflozin (Drug)
Arm 2
Active Comparator
干预措施: Glimepiride (Drug)
Arm 3
Active Comparator
干预措施: Dapagliflozin + Glimepiride (Drug)
结局指标
主要结局
Maximum plasma concentration and exposure to glimepiride and dapagliflozin when administered alone and administered together
时间窗: plasma concentrations will be measures as specified timepoints for 72 hours after each administred dose
次要结局
- Recorded adverse events(for 72 hours after each administered dose)
- Measures of the plasma concentration of the active metabolite of glimepiride when administered alone or coadministered with glimepiride(for 72 hours after each administered dose)
研究者
研究点 (1)
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