NCT07343245招募中1 期
A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics Drug-Drug Interaction of DW4421 and 3 NSAIDs in Healthy Adult Volunteers
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cmax,ss
研究概览
简要总结
Drug-Drug Interaction between DW4421 and three different kinds of NSAIDs
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Healthy adult aged 19 to 50 (inclusive) years, at the time of screening.
- •Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.
排除标准
- •Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
研究组 & 干预措施
Cohort 1, B
Experimental
干预措施: DW4421 (Drug)
Cohort 1, B
Experimental
干预措施: DW4421-N1 (Drug)
Cohort 2, C
Experimental
干预措施: DW4421 (Drug)
Cohort 2, C
Experimental
干预措施: DW4421-N2 (Drug)
Cohort 2, D
Experimental
干预措施: DW4421 (Drug)
Cohort 2, D
Experimental
干预措施: DW4421-N2 (Drug)
Cohort 3, E
Experimental
干预措施: DW4421 (Drug)
Cohort 3, E
Experimental
干预措施: DW4421-N3 (Drug)
Cohort 1, A
Experimental
干预措施: DW4421 (Drug)
Cohort 1, A
Experimental
干预措施: DW4421-N1 (Drug)
Cohort 3, F
Experimental
干预措施: DW4421 (Drug)
Cohort 3, F
Experimental
干预措施: DW4421-N3 (Drug)
结局指标
主要结局
Cmax,ss
时间窗: Baseline to Day 13 or Day 15
AUCτ,ss
时间窗: Baseline to Day 13 or Day 15
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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