Drug-drug Interaction Study to Evaluate the Pharmacokinetics and Safety of FYU-981 and Oxaprozin in Healthy Male Adults Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (Cmax: Maximum plasma concentration)
研究概览
简要总结
This is an open-label, 2-period add-on study to assess the drug-drug interaction between FYU-981 and oxaprozin. The purpose of this study is to investigate the pharmacokinetics of each period in a single administration of FYU-981 and concomitant administration of FYU-981 with oxaprozin at steady -state in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult healthy subjects
- •Body mass index: >=18.5 and <25.0
排除标准
- •Subject with any disease or any history of disease that might be unsuitable for participation in the clinical study
研究组 & 干预措施
Concomitant administration
Concomitant administration of FYU-981 with oxaprozin at steady state
干预措施: Oxaprozin (Drug)
Single dose
Single administration of FYU-981
干预措施: FYU-981 (Drug)
Concomitant administration
Concomitant administration of FYU-981 with oxaprozin at steady state
干预措施: FYU-981 (Drug)
结局指标
主要结局
Pharmacokinetics (Cmax: Maximum plasma concentration)
时间窗: 48 hours
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
时间窗: 48 hours
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
时间窗: 48 hours
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
时间窗: 48 hours
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
时间窗: 48 hours
Pharmacokinetics (kel: Elimination rate constant)
时间窗: 48 hours
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
时间窗: 48 hours
Pharmacokinetics (MRT: Mean residence time)
时间窗: 48 hours
Safety (Incidence of treatment-emergent adverse event)
时间窗: 20 days
次要结局
未报告次要终点