NCT03970434已完成1 期
Clinical Trial to Evaluate Drug Concentration of Metformin According to Sampling Method in Healthy Adult Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Concentration of Metformin
研究概览
简要总结
This study assess the drug concentration of metformin in healthy adult volunteers according to the sampling method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects who, at the time of screening, are the age of older than 19 years
- •Subjects who have BMI more than 17.5kg/m2 and less than 30.5kg/m2 and body weight more than 55kg
- •There is no congenital disease or within 3 years of chronic diseases
- •Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, ECG or clinical laboratory tests
- •Subjects who signed and dated the informed consent form(approved by IRB) after understanding fully to hear a detailed explanation in the clinical trial
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- •A subject with any history of gastrointestinal disease (e.g., Crohn's disease, acute or chronic pancreatitis, and others) and surgery (except for simple appendectomy or repair of a hernia), which can influence the absorption of investigational products
- •A subject who has the following clinical laboratory test results Liver Function Test (AST, ALT) > two times the upper limit of the normal range
- •History of regular alcohol consumption exceeding 210g/week(12g = 125 mL of wine, 10g = 250 mL of beer, 10g = 50 mL of hard liquor) within 6 months of Screening
- •A subject who has participated in any other clinical trials and had medication within 3 months prior to the first administration of investigational product.
- •A subject with a history of drug abuse or a positive urine drug screening for drug abuse within 1 year
- •A subject who has taken the drugs that induce and suppress drug- metabolizing enzymes within 30 days prior to investigational product administration
- •A smoker who consumes more than 20 cigarettes/day within 6 months
- •A subject who has taken any ethical-the-counter drug or has taken any over- the-counter drug within 10 days before the investigational product administration
- •A subject who has donated whole blood within 2 months or blood components within 1 month prior to the investigational product administration
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
研究组 & 干预措施
Metformin
Experimental
干预措施: Peripheral blood collection (Other)
Metformin
Experimental
干预措施: Venous blood collection (Other)
结局指标
主要结局
Concentration of Metformin
时间窗: 10 hours
Compare the concentration of Metformin measured from Venous blood collection and Peripheral blood collection.
次要结局
未报告次要终点
研究者
Min-Gul Kim, MD, PhD
Center for Clinical Pharmacology
Chonbuk National University Hospital
研究点 (2)
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