NCT03016494Unknown1 期
A Randomized, Open-label, Oral Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of Fixed-dose Combination of DWJ1386 Compared With Co-administration of DWC20155 and DWC20156 in Healthy Subjects
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2016年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to compare the safety and pharmacokinetics between co-administration and fixed dose combination of DWC20155 and DWC20156 in healthy subjects
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI≥18.5 and ≤27.0 kg/m2
- •No clinically significant findings
- •Age 19-55 years at screening
排除标准
- •Who has allergy to investigational product
研究组 & 干预措施
Test/Reference Drug
Experimental
DWJ1386 Tab. followed by co-administration of DWC20155 and DWC20156 Tab.
干预措施: Co-administration of DWC20155 and DWC20156 (Drug)
Test/Reference Drug
Experimental
DWJ1386 Tab. followed by co-administration of DWC20155 and DWC20156 Tab.
干预措施: DWJ1386 Tab. (Drug)
Reference/Test Drug
Experimental
co-administration of DWC20155 and DWC20156 Tab. followed by DWJ1386 Tab.
干预措施: Co-administration of DWC20155 and DWC20156 (Drug)
Reference/Test Drug
Experimental
co-administration of DWC20155 and DWC20156 Tab. followed by DWJ1386 Tab.
干预措施: DWJ1386 Tab. (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax)
时间窗: 0-24 hours
Area under the plasma concentration versus time curve (AUC)
时间窗: 0-24 hours
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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