A Randomized, Open-label, Multiple-dose, Crossover Phase I Clinical Trial to Compare the Safety, Pharmacokinetics and Pharmacodynamics of JW0301 to C2105 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- AUCτ, SS(Area under the plasma drug concentration-time curve within a dosing interval at steady state)
研究概览
简要总结
- To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions
- To evaluate the safety and drug tolerance after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions
详细描述
- It is analyzed for subjects who receive scheduled clinical trial drugs according to the clinical trial plan, have no significant violations in comparative analysis, and have completed all scheduled blood collection for pharmacokinetic evaluation.
To analyze subjects who receive clinical trial medications scheduled according to the clinical trial plan, have no significant violations in comparative analysis, and have assessable intragastric pH information by completing a 24-h pH monitoring measurement. 2. All subjects who received more than one dose of clinical trial drugs are evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 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
- •Healthy volunteers
排除标准
- •Subjects does not meet the Inclusion Criteria
研究组 & 干预措施
Group 1
Test Drug for Period I Reference Drug for Period II
干预措施: Reference Drug or Test Drug (Drug)
Group 2
Reference Drug for Period I Test Drug for Period II
干预措施: Reference Drug or Test Drug (Drug)
结局指标
主要结局
AUCτ, SS(Area under the plasma drug concentration-time curve within a dosing interval at steady state)
时间窗: 0 ~ 24h
Evaluation PK for Esomeprazole after multiple dose
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose
时间窗: Baseline versus Multiple dose during 7 days
Evaluation PD for ambulatory 24hr pH monitor
次要结局
未报告次要终点