NCT04703868已完成1 期
A Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of YPI 011 to Rabeprazole in Healthy Adult 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
- 88
- 试验地点
- 1
- 主要终点
- AUCt,ss
研究概览
简要总结
A study to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects
详细描述
This study is to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult 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
- •Age 19~55 years in healthy volunteers
- •BMI is more than 18.0 kg/m^2 , no more than 28.0 kg/m^2
- •Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
排除标准
- •Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- •Subjects who were judged ineligible by the investigator
研究组 & 干预措施
YPI-011 10/500mg
Experimental
Part A: 1 tablet administered before the breakfast during 7 days
干预措施: Rabeprazole Sodium 10mg (Drug)
YPI-011 20/500mg
Experimental
Part B: 1 tablet administered before the breakfast during 7 days
干预措施: Rabeprazole Sodium 20mg (Drug)
结局指标
主要结局
AUCt,ss
时间窗: From Day 1 up to Day 29
Evaluateion PK Rabeprazole after multiple dose
Integrated gastric acidity
时间窗: From Day 1 up to Day 28
Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 7th dose
次要结局
- Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 1 st dose(24 hours)
- Percent of time with gastric pH>4 for 24 hour interval after 1st and 7th dose(From Day 1 up to Day 28)
- Mean and median gastric pH after 1st and 7th dose(From Day 1 up to Day 28)
- AUCτ(From Day 1 up to Day 29)
- Cmax(From Day 1 up to Day 29)
- Tmax(From Day 1 up to Day 29)
- t1/2(From Day 1 up to Day 29)
- CL/F(From Day 1 up to Day 29)
- Vz/F(From Day 1 up to Day 29)
- Cmin,ss,(From Day 1 up to Day 29)
- Cmax,ss(From Day 1 up to Day 29)
- Cav,ss,(From Day 1 up to Day 29)
- Tmax,ss(From Day 1 up to Day 29)
- CLss/F(From Day 1 up to Day 29)
- Vss/F(From Day 1 up to Day 29)
- t1/2,ss(From Day 1 up to Day 29)
研究者
研究点 (1)
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