NCT05085184Unknown1 期
A Randomized, Open, Single-dose, 2x2x4 Replicate Crossover-design Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of UIC201806 and UIC201602 or Administration of UI018 in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- maximum concentration(Cmax)
研究概览
简要总结
This Study is to evaluate the safety and pharmacokinetics of a fixed dose combination formulation and co-administration.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects between the ages of 19 and 45 years at screening
- •Subjects whose body weight over 55 kg and ranged ± 20% of calculated Ideal body Weight(IBW) [ IBW (kg) = (height(cm) - 100) x 0.9 ]
- •Subjects able to read and understand a written informed consent, and willing to decide to participate in the study.
排除标准
- 未提供
研究组 & 干预措施
UI018
Experimental
干预措施: administration of UI018 (Drug)
UIC201806 and UIC201602
Active Comparator
干预措施: co-administration of UIC201806 and UIC201602 (Drug)
结局指标
主要结局
maximum concentration(Cmax)
时间窗: 0 to 96 hrs
area under the curve(AUC)
时间窗: 0 to 96 hrs
次要结局
未报告次要终点
研究者
研究点 (1)
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