A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-379 in Healthy Volunteers Under Fed Conditions
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- AUCt
研究概览
简要总结
A study to compare the pharmacokinetics and safety between CKD-379 and D759, D745, D029, D150 combination
详细描述
A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-379 in healthy volunteers under fed conditions
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 19 aged and 50 aged in healthy adult
- •18.0kg/m2≤body mass index(BMI)≤27.0kg/m2 and 50.0kg≤Body weight≤90.0kg
排除标准
- •Have clinical significant medical history or disease that blood, kidney(moderate nephropathy and etc.), endocrine system(type I or type II diabetes mellitus, diabetic ketoacidosis, diabetic coma and etc.), respiratory system, gastrointestinal system, urinary system, cardiovascular system(heart failure, Torsades de pointes and etc.), liver(moderate liver disorder and etc.), mental system, nervous system, immune system
- •Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery
- •Those who are pregnant or breastfeeding
- •Those who are deemed inappropriate to participate in clinical trial by investigators
研究组 & 干预措施
Sequence 1
Period 1: Reference drug(D759+D745+D029+D150) Period 2: Test drug(CKD-379)
干预措施: CKD-379 (Drug)
Sequence 1
Period 1: Reference drug(D759+D745+D029+D150) Period 2: Test drug(CKD-379)
干预措施: D759+D745+D029+D150 (Drug)
Sequence 2
Period 1: Test drug(CKD-379) Period 2: Reference drug(D759+D745+D029+D150)
干预措施: CKD-379 (Drug)
Sequence 2
Period 1: Test drug(CKD-379) Period 2: Reference drug(D759+D745+D029+D150)
干预措施: D759+D745+D029+D150 (Drug)
结局指标
主要结局
AUCt
时间窗: 0~48hours
Maximum plasma concentration of the drug
Cmax
时间窗: 0~48hours
Area under the concentration-time curve from the time of dosing to the last measurable concentration
次要结局
未报告次要终点