NCT02712619已完成1 期
An Open-label, Parallel Group Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics of 250/1000 mg of Metformin IR After Oral Administration in Healthy Male Volunteers
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
- 20
- 主要终点
- Maximum plasma concentration
研究概览
简要总结
Two doses of metformin with 12 hour interval
- low dose group (375/250 mg)
- high dose group (1000/1000mg)
详细描述
A study to evaluate and compare the pharmacokinetic-pharmacodynamic relationship between different metformin dose groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 20 to 45
- •Body weight 50 to 100 kg
- •fasting serum glucose 70 to 125 mg/dL
- •who provide informed consent voluntarily
排除标准
- •any significant renal, gastrointestinal, hepatic, and metabolic condition
- •any co/prior medication within 14 days of study drug administration
研究组 & 干预措施
metformin 250mg
Experimental
metformin 375/250 mg
干预措施: Metformin (Drug)
metformin 1000mg
Experimental
metformin 1000/1000 mg
干预措施: Metformin (Drug)
结局指标
主要结局
Maximum plasma concentration
时间窗: 0-12 hour
Area under the metformin concentration curve
时间窗: 0-12 hour
Area under the glucose curve
时间窗: 2-5 hour
次要结局
未报告次要终点
研究者
Jae Yong Chung
MD, PhD
Seoul National University Hospital
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