NCT05784155已完成1 期
A Randomized, Open-label, Multiple-dose, Crossover Phase I Clinical Trial to Compare the Safety, Pharmacokinetics and Pharmacodynamics After Oral Administration of JW0302 to C2206 in Healthy Adult Subjects
JW Pharmaceutical1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年3月10日最近更新:
适应症
干预措施
相关药物
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
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
Other
Test Drug for Period I Reference Drug for Period II
干预措施: Test Drug(JW0302) or Reference Drug(C2206) (Drug)
Group 2
Other
Reference Drug for Period I Test Drug for Period II
干预措施: Test Drug(JW0302) or Reference Drug(C2206) (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: up to 24 hours
Evaluation PK for JW0302 and C2206 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
研究者
研究点 (1)
Loading locations...
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