NCT04278391已完成1 期
A Randomized, Open Label, Single Dose, Crossover Study to Compare the Pharmacokinetics and Safety Between "DWJ1421" and "DWC201903" in Healthy Male Volunteers
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年7月2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
- 40
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This is a randomized, open label, single dose, crossover study to compare the pharmacokinetics and safety between "DWJ1421" and "DWC201903" in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Between 19 aged and 45 aged in healthy male adult
- •Body weight more than 50kg
- •Body Mass Index more than 18.0 and under 27.0
排除标准
- •Those who have clinical significant liver, kidney, digestive system, respiratory, endocrine, nervous system, hematology and oncology, cardiovascular, urinary diseae or past history
- •Those who have a gastrointestinal disease history that can effect drug absorption or surgery
- •Those who have hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Investigational product
研究组 & 干预措施
A (RT)
Experimental
Period 1 : Reference drug (DWC201903) Period 2 : Test durg(DWJ1421)
干预措施: DWC201903 (Drug)
B (TR)
Experimental
Period 1 : Test durg(DWJ1421) Period 2 : Reference drug (DWC201903)
干预措施: DWJ1421 (Drug)
结局指标
主要结局
Cmax
时间窗: 0, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14h
Maximum concentration of DWJ1421
AUClast
时间窗: 0, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14h
Area under the drug concentration-time curve
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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