Phase 1, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions Between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Oseltamivir carboxylate levels: Cmax and AUC(0-12)-
研究概览
简要总结
This study is a 4 period study to see if there is any interaction between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Oseltamivir 150mg and zanamivir 50mg/hour
Oseltamivir1 150mg PO q12h for 5 doses + Zanamivir IV continuous infusion at 50mg/hour for 72 hours
干预措施: Oseltamivir and Intravenous Zanamivir (Drug)
Zanamivir IV 50mg/hour
Zanamivir IV continuous infusion 50mg/hour for 16 hours (total dose of 800mg)
干预措施: Oseltamivir and Intravenous Zanamivir (Drug)
Oseltamivir 150mg and zanamivir 600mg
Oseltamivir 150mg PO q12h for 5 doses + Zanamivir 600mg IV q12h
干预措施: Oseltamivir and Intravenous Zanamivir (Drug)
Oseltamivir 150mg
Oseltamivir 150mg PO q12h for 3 days
干预措施: Oseltamivir and Intravenous Zanamivir (Drug)
结局指标
主要结局
Oseltamivir carboxylate levels: Cmax and AUC(0-12)-
时间窗: Period 2: Day 1, 2 & 3. Period 3: Day 1, 2 & 3. Period 4: Day 1, 2 & 3.
次要结局
- Safety:labs, vitals, ECGs & AEs.(Period 1-4, Days 1-4.)
- Oseltamivir: Cmax, AUC(0-12)& C12. Oseltamivir carboxylate: C12, AUC(0-24)& t1/2.(Period 2-4 Day 1-3)
- Zanamivir: Cmax, AUC(0-12), C12, t1/2, CL, tmax & V2 .(Period 1, 3 & 4 Day 1-3)