NCT03671941已完成1 期
A Randomized, Open-label, Single Dose, Crossover Study to Evaluate Pharmacokinetic Profiles and Safety/Tolerability of CKD-357 in Healthy 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
- 31
- 试验地点
- 1
- 主要终点
- AUCt of Ticagrelor
研究概览
简要总结
A randomized, open-label, single dose, crossover study to evaluate pharmacokinetic profiles and safety/tolerability of CKD-357 in healthy volunteers
详细描述
To healthy subjects of thirty(30), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group A
Active Comparator
D578 Tab. 1T
干预措施: D578 (Drug)
Group B
Experimental
CKD-357 Tab. 1T
干预措施: CKD-357 (Drug)
结局指标
主要结局
AUCt of Ticagrelor
时间窗: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
Area under the plasma concentration of Ticagrelor versus time curve from time zero to time of last quantifiable concentration
Cmax of Ticagrelor
时间窗: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
Maximum plasma concentration of Ticagrelor
次要结局
- Tmax of Ticagrelor(Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours)
- t1/2 of Ticagrelor(Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours)
- AUCinf of Ticagrelor(Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours)
- CL/F of Ticagrelor(Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours)
- Vd/F of Ticagrelor(Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours)
- AUCt of AR-C124910XX(Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours)
- Cmax of AR-C124910XX(Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours)
- AUCinf of AR-C124910XX(Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours)
- Tmax of AR-C124910XX(Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours)
- t1/2 of AR-C124910XX(Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Evaluate the Pharmacokinetics and Safety of HCP1704 in Healthy SubjectsHealth, SubjectiveNCT04081857Hanmi Pharmaceutical Company Limited48
已完成
1 期
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1801 in Healthy Male Subjects.HealthyNCT04084197Hanmi Pharmaceutical Company Limited61
已完成
1 期
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HGP1602 in Healthy SubjectsHealthyNCT04084184Hanmi Pharmaceutical Company Limited28
已完成
1 期
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1903HealthyNCT04762407Hanmi Pharmaceutical Company Limited57
已完成
1 期
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1801 in Healthy SubjectsHealthyNCT03826641Hanmi Pharmaceutical Company Limited85