NCT02502721已完成1 期
A Randomized, Open-labeled, Oral Dose, Crossover Design Clinical Trial to Evaluate Pharmacokinetics and Safety Between DWC20151 and DWC20152 in Healthy Male Subjects
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2015年6月最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
A randomized, open-labeled, oral dose, crossover design clinical trial to evaluate pharmacokinetics and safety between DWC20151 and DWC20152 in healthy male subjects.
详细描述
This study is to evaluate pharmacokinetics and safety between DWC20151 and DWC20152 in healthy male subjects.
Study design is randomized, open-labeled, oral dose, crossover design. This study will conducted with 2 separated part (Part A, Part B).
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
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects (18~55 years)
排除标准
- •Who has allergy to investigational product
研究组 & 干预措施
Part A
Experimental
To study effect of DWC20151 on DWC20152 PK
干预措施: DWC20151 (Drug)
Part B
Experimental
To study effect of DWC20152 on DWC20151 PK
干预措施: DWC20152 (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: 0~72hr
Area under the plasma concentration versus time curve (AUC)
时间窗: 0~72h
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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