NCT06119958招募中1 期
A Two-arm, Open-label, Single-sequence, Multiple Oral Dosings, Crossover Clinical Trial to Evaluate the Safety and the Pharmacokinetic Interaction of DWC202313 and DWC202314 in Healthy Adult Volunteers
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年10月27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
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Cmax,ss of DWC202313 and DWC202314
研究概览
简要总结
This is A two-arm, open-label, single-sequence, multiple oral dosings, crossover study to evaluate the safety and the pharmacokinetic interaction of DWC202313 and DWC202314 in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •over 19 year old
排除标准
- •Galactose intolerance
- •Lapp lactase deficiency
研究组 & 干预措施
DWC202313
Experimental
DWC202313
干预措施: DWC202313 (Drug)
DWC202314
Experimental
DWC202314
干预措施: DWC202314 (Drug)
结局指标
主要结局
Cmax,ss of DWC202313 and DWC202314
时间窗: Up to 14 days
AUCt,ss of DWC202313 and DWC202314
时间窗: Up to 14 days
次要结局
- Tmax,ss of DWC202313 and DWC202314(Up to 14 days)
- Cmin,ss of DWC202313 and DWC202314(Up to 14 days)
- t1/2 of DWC202313 and DWC202314(Up to 14 days)
- CLss/F of DWC202313 and DWC202314(Up to 14 days)
- Vdss/F of DWC202313 and DWC202314(Up to 14 days)
- PTF of DWC202313 and DWC202314(Up to 14 days)
研究者
研究点 (1)
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