An Open Label, 2-part, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between "DWN12088" and "Nebivolol" or "Paroxetine" in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUCt of DWN12088
研究概览
简要总结
An open label, 2-part, one-sequence, 3-period study to evaluate drug-drug interactions between DWN12088 and nebivolol or Paroxetine in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male adults aged ≥ 20 and ≤ 55 years at screening
- •Subjects who voluntarily decided to participate in the study and provided written consent to follow study compliance requirements after receiving a detailed explanation on this study and fully understanding the information
排除标准
- •Subjects unable to have the standard meal provided at the study site
- •Subjects who took (the day of taking the last dose) another investigational or bioequivalence study product within 180 days prior to the first dose
研究组 & 干预措施
DWN12088 and Nebivolol
Period 1 - Nebivolol A mg, Tablet, oral, once daily, Period 2 - DWN12088 X mg, Tablet, oral, twice daily, Period 3 - 1) Nebivolol A mg, Tablet, oral, once daily & DWN12088 X mg, Tablet, oral, twice daily, 2) DWN12088 X mg, Tablet, oral, once daily
干预措施: DWN12088 (Drug)
DWN12088 and Nebivolol
Period 1 - Nebivolol A mg, Tablet, oral, once daily, Period 2 - DWN12088 X mg, Tablet, oral, twice daily, Period 3 - 1) Nebivolol A mg, Tablet, oral, once daily & DWN12088 X mg, Tablet, oral, twice daily, 2) DWN12088 X mg, Tablet, oral, once daily
干预措施: Nebivolol (Drug)
DWN12088 and Paroxetine
Period 1 - DWN12088 X mg, Tablet, oral, once daily , Period 2 - Paroxetine B mg, Tablet, oral, once daily, Period 3 - 1) DWN12088 X mg, Tablet, oral, once daily & Paroxetine B mg, Tablet, oral, once daily, 2) Paroxetine B mg, Tablet, oral, once daily
干预措施: DWN12088 (Drug)
DWN12088 and Paroxetine
Period 1 - DWN12088 X mg, Tablet, oral, once daily , Period 2 - Paroxetine B mg, Tablet, oral, once daily, Period 3 - 1) DWN12088 X mg, Tablet, oral, once daily & Paroxetine B mg, Tablet, oral, once daily, 2) Paroxetine B mg, Tablet, oral, once daily
干预措施: Paroxetine (Drug)
结局指标
主要结局
AUCt of DWN12088
时间窗: Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12
AUCt of DWN12088
Cmax of Nebivolol
时间窗: Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8
Cmax of Nebivolol
AUCt of Nebivolol
时间窗: Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8
AUCt of Nebivolol
Cmax of DWN12088
时间窗: Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12
Cmax of DWN12088
次要结局
未报告次要终点