NCT02066207已完成1 期
Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetic Interaction Between Fenofibrate and Atorvastatin 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
- 30
- 试验地点
- 1
- 主要终点
- AUCt, Cmax,ss of fenofibric acid and atorvastatin
研究概览
简要总结
The purpose of this study is to evaluate a pharmacokinetic drug interaction between atorvastatin and fenofibrate in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •A healthy male volunteer between 19 and 55 years old.
- •BMI between 18.5 and
- •Able to participate in the entire trial
- •Signed the informed consent form prior to study participation.
排除标准
- •Clinically significant digestive system, cardiovascular system, respiratory system, endocrine system, hepatic system, renal system
- •sit SBP < 100mmHg or sit SBP ≥ 150mmHg or sit DBP < 70mmHg or sit DBP ≥ 100mmHg
- •Have acute infection history within 14 days
- •Have a allergic disease of need to treat
- •Have hypersensitivity reactions history for IP or any specific drugs.
- •AST, ALT or Total bilirubin > UNL * 1.5
- •Estimated GFR < 60 ml/min
- •Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •A heavy smoker (cigarette > 10 cigarettes per day)
- •A heavy alcohol consumer (alcohol > 140g/week)
- •A heavy grapefruit consumer (more than 1cup per a day)
- •Have a history of drug abuse or showed a positive for urine drug test.
- •Administrated IP within 60 days prior to screening
- •Rhabdomyolysis include of having a history or family history of genetic muscle diseases
- •Positive for HIV antibody, HBsAg, HCV antibody test
- •Previously donate whole blood within 60 days or component blood within 30 days
- •Subject takes ethical drug or herbal medicine within 30 days
- •Clinically significant laboratory test result
- •An impossible one who participates in clinical trial by investigator's decision including other reason
研究组 & 干预措施
Fenofibrate
Experimental
Subjects received Fenofibrate
干预措施: Fenofibrate (Drug)
Atorvastatin
Experimental
Subjects received Atorvastatin
干预措施: Atorvastatin (Drug)
Fenofibrate and Atorvastatin
Experimental
Subjects received Fenofibrate and Atorvastatin
干预措施: Fenofibrate (Drug)
Fenofibrate and Atorvastatin
Experimental
Subjects received Fenofibrate and Atorvastatin
干预措施: Atorvastatin (Drug)
结局指标
主要结局
AUCt, Cmax,ss of fenofibric acid and atorvastatin
时间窗: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h
次要结局
- Tmax,ss, Cmin,ss, t1/2, CL/Fss, Vd/Fss, %swing, Cav, %fluctuation(0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h)
研究者
研究点 (1)
Loading locations...
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