A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Warfarin in Healthy Male and Female Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Area Under the Curve from time zero to infinite (AUC0-infinity)
研究概览
简要总结
The purpose of this study is to determine if Warfarin is affected by PA21.
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
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Written informed consent
排除标准
- •No significant medical conditions
- •Pregnancy
研究组 & 干预措施
PA21 and Warfarin with food
The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Warfarin will be 10 mg/day
干预措施: PA21 (Drug)
PA21 and Warfarin with food
The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Warfarin will be 10 mg/day
干预措施: Warfarin (Drug)
No PA21; Warfarin with food
The maximum dosage of Warfarin will be 10 mg/day
干预措施: Warfarin (Drug)
PA21 with food and Warfarin 2hrs later
The maximum dose of PA21 will be 15 g/day. The maximum dose of Warfarin will be 10 mg/day
干预措施: PA21 (Drug)
PA21 with food and Warfarin 2hrs later
The maximum dose of PA21 will be 15 g/day. The maximum dose of Warfarin will be 10 mg/day
干预措施: Warfarin (Drug)
结局指标
主要结局
Area Under the Curve from time zero to infinite (AUC0-infinity)
时间窗: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post Warfarin dose on Days 0, 11, 22
Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time
Maximum observed plasma concentration (Cmax)
时间窗: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post Warfarin dose on days 0, 11, 22
Area Under the Curve from time zero to 24 hours (AUC0-24)
时间窗: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post Warfarin dose on Days 0, 11, 22
Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours
次要结局
未报告次要终点