NCT03793985已完成1 期
Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337 in Healthy Adult 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
- 45
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Compare the pharmacokinetic characteristics and safety between CKD-391 tablet and D337, D337 combination
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
- •Over 50 kg, BMI between 18.0-29.0 kg/m2
- •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
- •Subjects with abnormal lab values at least one below 1) AST or ALT>2 fold of upper normal limit 2) Total bilirubin>2 fold of upper normal limit 3) CK>2 fold of upper normal limit 4) Estimated Glomerular filtration rate<60mL/min/1.73m2
- •Drink over 21 units/week (1 unit= 10g=12.5mL of pure alcohol) or unable to stop drinking during clinical trials
- •Smoke over 10 cigarettes per day or unable to stop smoking
- •Subjects who previously participated in other clinical trials within 90 days
- •Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
- •Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 10 days.
- •Taking medications which induce or block medication metabolism
- •History of drug abuse
- •Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 7 days.
- •Disagree to contraception
- •Subjects who are in any conditions impossible participating in the clinical trials
研究组 & 干预措施
A (R+T+R+T)
Experimental
Period 1 : R Period 2 : T Period 3 : R Period 4 : T
干预措施: T (Drug)
A (R+T+R+T)
Experimental
Period 1 : R Period 2 : T Period 3 : R Period 4 : T
干预措施: R (Drug)
B (T+R+T+R)
Active Comparator
Period 1 : T Period 2 : R Period 3 : T Period 4 : R
干预措施: T (Drug)
B (T+R+T+R)
Active Comparator
Period 1 : T Period 2 : R Period 3 : T Period 4 : R
干预措施: R (Drug)
结局指标
主要结局
Cmax
时间窗: 0~72hours
To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax
AUCt
时间窗: 0~72hours
To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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