An Open-Label, Single-Dose, Randomized, Crossover Pharmacokinetics And Relative Bioavailability Study Of Three Modified 40 Mg Oxycodone Formulations Compared With 40 Mg Pf-00345439 Capsule Formulation In Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) (if data permit, otherwise Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUClast]) of oxycodone.
研究概览
简要总结
To estimate the pharmacokinetics and relative bioavailability of oxycodone after administration of 40 mg doses of four PF-00345439 formulations and oxycodone in solution
详细描述
This study will estimate the PK and relative bioavailability of oxycodone following single oral 40-mg doses of 3 modified PF-00345439 Formulations B, C, and D compared with the reference Formulation A under fed conditions.
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 and/or female subjects between the ages of 21 and 55 years, inclusive
排除标准
- •Evidence or history of clinically significant diseases
研究组 & 干预措施
Oxycodone Formulation A Capsule
single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block
干预措施: Oxycodone (Drug)
Oxycodone Formulation D Capsule
single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block
干预措施: Oxycodone (Drug)
Oxycodone Formulation B Capsule
single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block
干预措施: Oxycodone (Drug)
Oxycodone Formulation C Capsule
single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block
干预措施: Oxycodone (Drug)
Oxycodone Oral Solution
40 mg oxycodone oral solution (5 mg/5 ml) under 50 mg naltrexone block
干预措施: Oxycodone (Drug)
结局指标
主要结局
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) (if data permit, otherwise Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUClast]) of oxycodone.
时间窗: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose
Maximum Observed Plasma Concentration (Cmax)
时间窗: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose
次要结局
- Adverse events, vital signs and laboratory parameters.(0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of oxycodone, as data permit.(0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of oxycodone, as data permit.(0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose)
- Plasma Decay Half-Life of oxycodone, as data permit.(0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose)
- Concentration at time 24 hours (C24) of oxycodone, as data permit.(0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose)