A Phase 1, Open Label, Randomized, Multiple Dose Study To Assess The Two-Way Drug Interaction Between Sitaxsentan And Low Dose Ritonavir In Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- The comparison of area under the curve of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone.
研究概览
简要总结
The study is to assess if sitaxsentan and ritonavir will affect the blood levels of each other when coadministered.
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
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects and/or women of non-child bearing potential.
- •Subjects (because of teratogenic risk of sitaxsentan) between the ages of 21 and 55 years, inclusive.
- •Signed informed consent.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- •History of significant alcohol and drug use.
- •Has hepatic dysfunction.
研究组 & 干预措施
Treatment A
干预措施: Sitaxentan (Drug)
Treatment B
干预措施: Ritonavir (Drug)
Treatment C
干预措施: Sitaxsentan (Drug)
Treatment C
干预措施: Ritonavir (Drug)
结局指标
主要结局
The comparison of area under the curve of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone.
时间窗: 24 hours
The comparison of peak plasma concentration of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone.
时间窗: 24 hours
The comparison of peak plasma concentration of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone.
时间窗: 24 hours
The comparison of area under the curve of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone.
时间窗: 24 hours
次要结局
未报告次要终点