NCT05282914已完成1 期
A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics Between "UI058" and "UIC202004" in Healthy Subjects
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
- 41
- 试验地点
- 1
- 主要终点
- AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state
研究概览
简要总结
A Study to compare pharmacokinetics, pharmacodynamics and safety of UI058 and UIC202004 in healthy subjects
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects able to read and understand a written informed consent, and willing to decide to participate in the study
- •Healthy subjects between the ages of 19 and 55 years at screening
- •Body weight more than 50.0kg(male)/45.0kg(female)
- •Body Mass Index more than 18.0kg/m2 and under 30.0kg/m2
排除标准
- •Have clinically significant disease that hepatobiliary system, kidney, respiratory system, nervous system, hemato-oncology disease, cardiovascular system
- •Have a gastrointestinal disease history that can effect drug absorption or surgery
- •Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of investigational product
研究组 & 干预措施
UI058
Experimental
干预措施: administration of UI058 (Drug)
UIC202004
Active Comparator
干预措施: administration of UIC202004 (Drug)
结局指标
主要结局
AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state
时间窗: Day 7, 0~24hours
evaluation PK for Rabeprazole after multiple dose
percent change from baseline in integrated gastric acidity for 24-hour interval after 7th dose
时间窗: baseline versus multiple dose during 7days
evaluation PD for ambulatory 24hour pH monitor
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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