Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D090 and D337 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- AUCt
研究概览
简要总结
phase I clinical trial to compare the pharmacokinetics and safety of CKD-391 with co-administration of D090 and D337 in healthy adult volunteers
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
- •Between 19 aged and 45 aged in healthy male adult
- •Subjects in good health as determined by physical exams and medical examinations. No congenital or chronic diseases and no abnormal signs determined by medical examinations.
- •Not abnormal or not clinically significant lab values.
- •Subjects who signed informed consent form with good understandings after explanations by investigators.
排除标准
- •No history or presence of clinically significant diseases.
- •Subjects showing adverse reaction to investigational product
- •Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
- •History of myopathy
- •unable to stop drinking and smoking during clinical trials
- •Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
- •History of drug abuse
- •Disagree to contraception
- •Subjects who are in any conditions impossible participating in the clinical trials
研究组 & 干预措施
Group C
T+R+T+R Period 1 : T Period 2 : R Period 3 : T Period 4 : R
干预措施: D090, D337 (Drug)
Group A
R+R+T+T Period 1 : R Period 2 : R Period 3 : T Period 4 : T
干预措施: CKD-391 10/10mg (Drug)
Group A
R+R+T+T Period 1 : R Period 2 : R Period 3 : T Period 4 : T
干预措施: D090, D337 (Drug)
Group B
R+T+R+T Period 1 : R Period 2 : T Period 3 : R Period 4 : T
干预措施: CKD-391 10/10mg (Drug)
Group B
R+T+R+T Period 1 : R Period 2 : T Period 3 : R Period 4 : T
干预措施: D090, D337 (Drug)
Group C
T+R+T+R Period 1 : T Period 2 : R Period 3 : T Period 4 : R
干预措施: CKD-391 10/10mg (Drug)
Group D
T+T+R+R Period 1 : T Period 2 : T Period 3 : R Period 4 : R
干预措施: CKD-391 10/10mg (Drug)
Group D
T+T+R+R Period 1 : T Period 2 : T Period 3 : R Period 4 : R
干预措施: D090, D337 (Drug)
结局指标
主要结局
AUCt
时间窗: 0~72hours
To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt 1) Atorvastatin, unconjugated ezetimibe(AUCt)
Cmax
时间窗: 0~72hours
To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax 1) Atorvastatin, unconjugated ezetimibe(Cmax)
次要结局
未报告次要终点