A Randomized, Open-label, Single Dose, 2-period, 2-treatment, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-379 and Coadministration of D759, D745 and D150 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
A study to compare the pharmacokinetics and safety/tolerability between CKD-379 tablet and D759, D745, D150 combination
详细描述
A randomized, open-label, single dose, 2-period, 2-treatment, crossover study to compare the pharmacokinetics and safety/tolerability of CKD-379 in healthy subjects 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
- •50.0kg≤Body weight≤90.0kg and 18.0kg/m2≤body mass index(BMI)≤27.0kg/m2
排除标准
- •Have clinical significant medical history or disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, digestive system, urinary system, endocrine system(Type I or Type II Diabetes Mellitus, diabetic ketoacidosis etc.), hematological system, cardiovascular system(heart failure, Torsades de pointes etc.), mental illness
- •Have clinical significant medical history or disease that urinary tract infection or genital infection including urosepsis, pyelonephritis
- •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+D150) Period 2: Test drug(CKD-379)
干预措施: CKD-379 (Drug)
Sequence 1
Period 1: Reference drug(D759+D745+D150) Period 2: Test drug(CKD-379)
干预措施: D759+D745+D150 (Drug)
Sequence 2
Period 1: Test drug(CKD-379) Period 2: Reference drug(D759+D745+D150)
干预措施: CKD-379 (Drug)
Sequence 2
Period 1: Test drug(CKD-379) Period 2: Reference drug(D759+D745+D150)
干预措施: D759+D745+D150 (Drug)
结局指标
主要结局
Cmax
时间窗: 0~48hours
Maximum plasma concentration of the drug
AUClast
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