Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of CKD-391 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 主要终点
- AUClast
研究概览
简要总结
A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.
详细描述
To compare the CKD-391 (Experimental product) to the dose Atorvastatin calcium and Ezetimibe combination in health male subjects is the purpose of this trial.
Following are evaluated in this trial; Characteristics and safety/Tolerability Of CKD-391.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Bwt >=50kg, BMI 18.5~25
- •signed the informed consent form prior to the study participation
排除标准
- •- Clinically significant disease
- •Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug
- •Clinically significant allergic disease
- •Impossible to taking the institutional standard meal
- •Previously donate whole blood within 60 days or component blood within 20 days
- •Previously participated in other trial within 90 days
- •Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette > 10 cigarettes per day)during clinical trials
- •An impossible one who participates in clinical trial by investigator's decision including laboratory test result
研究组 & 干预措施
TR group
CKD-391 and combination dose of Atrovastatin and Ezetimibe in order
干预措施: CKD-391 (Drug)
TR group
CKD-391 and combination dose of Atrovastatin and Ezetimibe in order
干预措施: Atrovastatin and Ezetimibe combination therapy (Drug)
RT group
combination dose of Atrovastatin and Ezetimibe and CKD-391 in order
干预措施: CKD-391 (Drug)
RT group
combination dose of Atrovastatin and Ezetimibe and CKD-391 in order
干预措施: Atrovastatin and Ezetimibe combination therapy (Drug)
结局指标
主要结局
AUClast
时间窗: up to 96 hours post dose
Cmax
时间窗: up to 96 hours post dose
次要结局
- T1/2(up to 96 hours post dose)
- Tmax(up to 96 hours post dose)
- AUCinf(up to 96 hours post dose)
- Adverse events(up to 24days post dose)