NCT02088918已完成1 期
A Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared With a Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet Under Fasting Conditions in Healthy Male 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
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- AUC last
研究概览
简要总结
A Randomized, Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared with a Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet under Fasting Conditions in Healthy Male Subjects
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
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 20 and 40
- •Signed informed consent
排除标准
- •Has a history of hypersensitivity to IP ingredients
- •Hypertension or hyportension
研究组 & 干预措施
Nateglinide+Metformin
Active Comparator
coadministration of nateglinide and metformin
干预措施: Nateglinide (Drug)
Nateglinide+Metformin
Active Comparator
coadministration of nateglinide and metformin
干预措施: Metformin (Drug)
Nateglinide/Metformin
Experimental
Nateglinide/Metformin tablet
干预措施: Nateglinide/Metformin (Drug)
结局指标
主要结局
AUC last
时间窗: 0-~24hrs
Cmax
时间窗: 0~24hrs
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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