NCT04304547已完成1 期
Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-348 With Co-administration of CKD-828, D097 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
- 15
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D097 and D337 in healthy adult volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •19 ≤ age ≤ 45
- •Health Volunteers
- •Subject who agreeds to participate in this clinical trial voluntarily
排除标准
- •Subject who cannot participate in a clinical trial based on the PI's judgment
研究组 & 干预措施
Sequence A
Active Comparator
CKD-828, D097, D337, CKD-348 T1, CKD-348 T2
干预措施: CKD-828, D097, D337, CKD-348 T1, CKD-348 T2 (Drug)
Sequence B
Active Comparator
CKD-828, D097, D337, CKD-348 T1, CKD-348 T2
干预措施: CKD-348 T1, CKD-348 T2, CKD-828, D097, D337, (Drug)
Sequence C
Active Comparator
CKD-828, D097, D337, CKD-348 T1, CKD-348 T2
干预措施: CKD-348 T2, CKD-348 T1, CKD-828, D097, D337 (Drug)
结局指标
主要结局
Cmax
时间窗: 0 hour ~ 144 hr
Maximum plasma concentration of the drug
AUCt
时间窗: 0 hour ~ 144 hour
Area under the concentration time curve from time zero to time
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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