NCT02069821已完成1 期
An Open-label, Multiple-dosing, Two-arms, One-sequence Study to Evaluate the Safety and Pharmacokinetics After Co-administration of Exforge® (Amlodipine Besylate/Valsartan) and Lipitor® (Atorvastatin Ca) in Healthy Male 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
- 56
- 试验地点
- 1
- 主要终点
- To Evaluate PK interaction of amlodipine and valsartan
研究概览
简要总结
The purpose of the study is to assess the pharmacokinetic interactions between amlodipine besylate/valsartan and atorvastatin 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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male volunteers in the age between 20 and 45 years old
- •The weight is over 55kg and 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 routine laboratory data obtained prior to study drug administration
- •Willing to adhere to protocol requirements and sign a informed consent form
排除标准
- •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 clinically significant allergies including drug allergies or anaphylaxis to amlodipine, valsartan and/or atorvastatin
- •Subjects with a history of myopathy
- •Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Subject with the mean blood pressure of siDBP ≥ 150 mmHg or ≤ 90 mmHg and/or siSBP ≥ 95 mmHg or ≤ 50 mmHg at the screening visit
- •Subjects with abnormal HDL-cholesterol(<35mg/dL)
- •Subjects with abnormal of serum potassium concentration (<3.4 mEq/L of >5.5 mEq/L in screening visit)
- •Subjects with a history of drug abuse
- •Subjects taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
- •Subjects who have received any drugs that might confound the results of the trial based on medical judgement by investigators within 14days prior to drug administration and OTC or vitamin within 7days prior to drug administration
- •Participated in a previous clinical trial within 60 days prior to dosing
- •Donated blood within 60 days prior to dosing
- •Subjects with a history of alcohol abuse(over 21 units/week, 1 unit = 10 g of pure alcohol) or is difficult to stop drinking within study
- •Subjects have ever smoked over 10 cigarette per day within 3 months prior to drug administration
- •Subjects with a history of caffeine abuse or or is difficult to stop drinking within study
- •Subjects with biliary obstruction
- •Subjects with hepatic dysfunction (AST or ALT >3 times to accepted normal range)
- •Subjects with moderate renal dysfunction (creatinine clearance (CLcr) < 30mL/min)
- •Subjects considered as unsuitable based on medical judgement by investigators
研究组 & 干预措施
Group B
Experimental
single administration : atorvastatin 40mg, qd, 7days(oral)
干预措施: combination administration (Drug)
Group A
Experimental
single administration : amlodipine/valsartan 10/160mg, qd, 10days(oral)
干预措施: combination administration (Drug)
结局指标
主要结局
To Evaluate PK interaction of amlodipine and valsartan
时间窗: from pre dosing to 24hr post dose
AUCss,τ, Css,max
To Evaluate PK interaction of atorvastatin and 2-OH atorvastatin
时间窗: from pre dosing to 24hr post dose
AUCss,τ, Css,max
次要结局
- To Evaluate PK interaction of amlodipine and valsartan(from pre dosing to 24hr post dose)
- To Evaluate PK interaction of atorvastatin and 2-OH atorvastatin(from pre dosing to 24hr post dose)
研究者
研究点 (1)
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