NCT03809260已完成不适用
A Clinical Trial for Analysis of Intestinal Microbiome Affecting Pharmacokinetics, Pharmacodynamics, and Safety of Metformin in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Compare the gut microbiome species change
研究概览
简要总结
This clinical trial is intended to evaluate the effects of the changes in intestinal microbiome by antibiotics (PO vancomycin) on the pharmacokinetic /pharmacodynamic and safety profiles of metformin in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 19 to 45, 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)>1.5 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
Part 1
Experimental
Metformin/Vancomycin
干预措施: Metformin (part 1) (Drug)
Part 1
Experimental
Metformin/Vancomycin
干预措施: Vancomycin (Drug)
Part 2
Experimental
Metformin
干预措施: Metformin (part 2) (Drug)
结局指标
主要结局
Compare the gut microbiome species change
时间窗: Day 1/4/16/19
Compare how the gut microbiome species change after metformin (or vancomycin) multiple dosing
次要结局
- Compare the maximum plasma concentration (Cmax) of metformin(Day 4/19 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post-dose))
- Compare the maximum blood glucose concentration (Gmax)(Day 1/4/16/19 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours))
- Compare the area under the plasma concentration versus time curve (AUC) of metformin(Day 4/19 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post-dose))
- Compare the area under the blood glucose concentration versus time curve (AUC)(Day 1/4/16/19 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours))
研究者
Jae Yong Chung, MD, PhD
Professor
Seoul National University Bundang Hospital
研究点 (1)
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