NCT00842556已完成1 期
Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin 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
- 18
- 试验地点
- 1
- 主要终点
- Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs
研究概览
简要总结
To assess the effect of glimepiride on the PK of dapagliflozin and the effect of dapagliflozin on the PK of glimepiride, when co-administered in healthy subjects (Phase A) and to assess the effect of sitagliptin on the PK of dapagliflozin and the effect of dapagliflozin on the PK of sitagliptin, when co-administered in healthy subjects (Phase B)
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
- •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 12 weeks after the last dose of investigational product
- •Abnormal liver functions tests (ALT, AST or total bilirubin > 10% above ULN)
- •History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months
- •History of allergy to SGLT@ inhibitors, DPP$ inhibitors or sulfonylurea or related compounds
- •Prior exposure to dapagliflozin, sitagliptin and glimepiride within 3 months of Day -1
- •History of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections
研究组 & 干预措施
Dapagliflozin
Active Comparator
干预措施: Dapagliflozin (Drug)
Glimepiride
Active Comparator
干预措施: Glimepiride (Drug)
Dapagliflozin + Glimepiride
Active Comparator
干预措施: Dapagliflozin (Drug)
Dapagliflozin + Glimepiride
Active Comparator
干预措施: Glimepiride (Drug)
Sitagliptin
Active Comparator
干预措施: Sitagliptin (Drug)
Dapagliflozin + Sitagliptin
Active Comparator
干预措施: Dapagliflozin (Drug)
Dapagliflozin + Sitagliptin
Active Comparator
干预措施: Sitagliptin (Drug)
结局指标
主要结局
Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs
时间窗: 72 hours after dosing
次要结局
- To assess the safety and tolerability in healthy subjects(15 time points up to 72 hours after dosing)
研究者
研究点 (1)
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