NCT04335526已完成1 期
A Clinical Study for Assessing the Effect of Change of Bile Acid Pool on the Pharmacodynamics and Safety of Metformin and Intestinal Microbiome Profiles in Healthy 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
- 15
- 试验地点
- 1
- 主要终点
- Compare the maximum blood glucose concentration (Gmax)
研究概览
简要总结
This clinical trial is intended to evaluate the effect of change of bile acid pool with cholestyramine on the pharmacodynamics and safety of metformin and intestinal microbiome profiles in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 19 to 50, healthy male subjects(at screening)
- •Body weight between 50.0 kg - 100.0 kg, BMI between 18.0 - 28.0 kg/m2
- •Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress
排除标准
- •Subject who has a past or present history of any diseases following below.(liver, kidney, neurology, immunology, pulmonary, endocrine, hematology, oncology, cardiology, mental disorder)
- •Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery (appendectomy, hernioplasty are excluded)
- •Serum AST(SGOT), ALT(SGPT)>2 times upper limit of normal range MDRD eGFR <80mL/min/1.73m2
- •Subject who had drug (Aspirin, antibiotics) hypersensitivity reaction
- •Subject who already participated in other trials in 3 months
- •Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently
研究组 & 干预措施
Metformin with cholestyramine
Other
干预措施: Cholestyramine Resin (Drug)
结局指标
主要结局
Compare the maximum blood glucose concentration (Gmax)
时间窗: Day 1/2/8/9 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)
Compare the area under the blood glucose concentration versus time curve (AUC) between meformin alone and meformin with cholestyramine
Compare the gut microbiome species change
时间窗: Day 1/2/8/9
Compare how the gut microbiome species change between meformin alone and meformin with cholestyramine
次要结局
未报告次要终点
研究者
Jae Yong Chung, MD, PhD
Professor
Seoul National University Hospital
研究点 (1)
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