NCT01765023已完成1 期
An Open-label, Fixed-sequence Study to Evaluate Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- To Evaluate PK interaction of atorvastatin and metformin
研究概览
简要总结
The purpose of the study is to assess the pharmacokinetic interactions between atorvastatin and metformin single or co-administered in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Willing to adhere to protocol requirements and sign a informed consent form
- •Healthy male volunteers who are in age range of 20-55 years and the weight range is not exceed ±20% of ideal weight. Ideal weight = [height -100]*0.9
- •Subjects with no history of any significant chronic disease
- •Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data for this trial by investigators
排除标准
- •Subjects taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
- •Subjects with Symptoms of acute disease within 28days prior to study medication dosing
- •Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines
- •Subjects with a history of abdominal surgery within food and water limit
- •Subjects with a history of clinically significant allergies including drug allergies
- •Subjects with anaphylaxis to atorvastatin and/or metformin
- •Subjects with a history or plan iodine radiotherapy within 28 days prior to drug administration
- •Subjects with a history of myopathy
- •Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Clinical laboratory test values are outside the accepted normal range
- •AST or ALT >1.25 times to normal range
- •Total bilirubin >1.5 times to normal range
- •Creatinine clearance <90 mL/min
- •Subjects with a history of drug, caffeine and alcohol abuse(caffeine > 5cups/day, cigarette > 10/day, alcohol > 30g/day) or have ever drank within 7 days prior to drug administration
- •Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
- •Donated blood within 60 days prior to dosing
- •Participated in a previous clinical trial within 60 days prior to dosing
- •Subjects who have received any drugs that might confound the results of the trial based on medical judgement by investigators within 10days prior to drug administration
- •Subjects considered as unsuitable based on medical judgement by investigators
结局指标
主要结局
To Evaluate PK interaction of atorvastatin and metformin
时间窗: Throughout the study
次要结局
- To Evaluate PK interaction of 2-OH-atorvastatin and metformin(Throughout the study)
研究者
研究点 (2)
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