NCT03016520Unknown1 期
An Open-label, Randomized, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetics and Safety of DWJ1392 and DWC20164 in Healthy Male Volunteers
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2017年1月9日最近更新:
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
- 28
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC)
研究概览
简要总结
The purpose of this study to Compare the safety and pharmacokinetics of DWJ1392 and DWC20164 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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •No clinically significant findings
- •Age 19-50 years at screening
排除标准
- •Who has allergy to investigational product
研究组 & 干预措施
Test drug
Experimental
DWJ1392
干预措施: DWJ1392 (Drug)
Reference drug
Experimental
DWC20164
干预措施: DWC20164 (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC)
时间窗: 0-72 hours
Maximum Plasma Concentration (Cmax)
时间窗: 0-72 hours
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1568 in Healthy Adult VolunteersHealthy VolunteersNCT06119945Daewoong Pharmaceutical Co. LTD.44
招募中
1 期
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1567 in Healthy Adult VolunteersHealthy VolunteersNCT06109259Daewoong Pharmaceutical Co. LTD.44
招募中
1 期
To Compare the Pharmacokinetic Characteristics of the Fixed-dose Combination Compared to the Loose CombinationFDCDiabetes Mellitus, Type 2NCT05737771Daewoong Pharmaceutical Co. LTD.40
Unknown
1 期
Phase 1 Study to Evaluate the Pharmacokinetics and Safety Following SC Administration of DWJ108J in Patients With Prostate CancerProstate CancerNCT03029533Daewoong Pharmaceutical Co. LTD.44
已完成
1 期
Phase 1 Study of DW-0919 & DW-0920 in Healthy Male Volunteers Under Fasting ConditionHealthyNCT01606059Daewon Pharmaceutical Co., Ltd.30