NCT01068756终止1 期
Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- AUC (area under the concentration-time curve) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data
研究概览
简要总结
The purpose of the study is to assess the effects of rifampin on the pharmacokinetics of dapagliflozin
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Body Mass Index (BMI) of 18 to 32 inclusive
- •Women who are not of childbearing potential and men, ages 18 to 45
排除标准
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (ECG) or clinical laboratory determinations
- •Glucosuria
- •Abnormal liver function tests
研究组 & 干预措施
Dapagliflozin/Rifampin
Other
干预措施: Dapagliflozin (Drug)
Dapagliflozin/Rifampin
Other
干预措施: Rifampin (Drug)
结局指标
主要结局
AUC (area under the concentration-time curve) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data
时间窗: Days 1 to 3 and Days 9 to 11
次要结局
- Cmax (maximum observed concentration) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data(Days 1 to 3 and Days 9 to 11)
- Tmax (time of maximum observed concentration) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data(Days 1 to 3 and Days 9 to 11)
研究者
研究点 (1)
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