The Cross-Over Study to Investigate the Effect of Proton Pump Inhibitor on the Pharmacokinetics and Pharmacodynamics of Metformin in Healthy Korean Men.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUC(area under the plasma concentration-time curve)
研究概览
简要总结
This study aims to investigate the effect of proton pump inhibitor on the pharmacokinetics and pharmacodynamics of metformin in healthy Korean men.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male subject aged 20 to 45 at screening
- •A body weight in the range of 50 kg (inclusive) - 100 kg (inclusive) with ideal body weight range of +- 25%
- •subjects who decide to participate voluntarily and write a informed consent form
排除标准
- •subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
- •Subject judged not eligible for study participation by investigator.
研究组 & 干预措施
Metformin only
metformin 750mg(D-1), metformin 500mg (D1)
干预措施: Metformin (Drug)
Metformin and Pantoprazole
pantoprazole 40mg(D-2)/ metformin 750mg + pantoprazole 40mg(D-1)/metformin 500mg + pantoprazole 40mg(D1)
干预措施: Metformin and Pantoprazole (Drug)
Metformin and Rabeprazole
rabeprazole 20mg(D-2)/metformin 750mg+rabeprazole 20mg(D-1)/metformin 500mg+rabeprazole 20mg(D1)
干预措施: Metformin and Rabeprazole (Drug)
结局指标
主要结局
AUC(area under the plasma concentration-time curve)
时间窗: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose
AUC(area under the plasma concentration-time curve), Cmax(maximum plasma concentration), t1/2
次要结局
- AUG(total area under the serum concentration-time curve for glucose)(predose and 15, 30, 45, 60, 90, 120, 150, 180min oral glucose tolerance test)
研究者
Jae Yong Chung
Assistant Professor
Seoul National University Bundang Hospital