NCT05699070Enrolling By Invitation1 期
An Open-label Phase 1 Study to Evaluate Pharmacokinetic/Pharmacodynamic Drug-drug Interactions and Safety/Tolerability of DWC202211 and DWC202212 Compared to Coadministration in Healthy
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年2月15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
- Enrolling By Invitation
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
An open-label phase 1 study to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability of DWC202211 and DWC202212 compared to coadministration in healthy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged ≥ 19 and ≤ 50 years at screening
- •Subjects with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 27.0 kg/m2 at screening
- •※ BMI (kg/m2) = body weight (kg)/[height (m)]2
- •Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information
- •Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc.
排除标准
- 未提供
研究组 & 干预措施
DWC202211
Experimental
干预措施: DWC202211 100mg (Drug)
DWC202212
Experimental
干预措施: DWC202212 5mg (Drug)
DWC202211 + DWC202212
Experimental
干预措施: DWC202211 100mg + DWC202212 5mg (Drug)
结局指标
主要结局
Cmax
时间窗: up to 27 days
AUClast
时间窗: up to 27 days
次要结局
- DWC202212 Cavg,ss(up to 27 days)
- DWC202212 CLss/F(up to 27 days)
- DWC202212 Vdss/f(up to 27 days)
- DWC202212 PTF(up to 27 days)
- DWC202211 Tmax,ss(up to 27 days)
- DWC202211 Cmin,ss(up to 27 days)
- DWC202211 T1/2,ss(up to 27 days)
- DWC202212 T1/2,ss(up to 27 days)
- DWC202212 Cmin,ss(up to 27 days)
- DWC202211 Cavg,ss(up to 27 days)
- DWC202211 CLss/F(up to 27 days)
- DWC202211 Vdss/f(up to 27 days)
- DWC202211 PTF(up to 27 days)
- DWC202212 Tmax,ss(up to 27 days)
研究者
研究点 (1)
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