An Open-label, Single-dose, Randomized, Three-way Crossover Study to Estimate the Effects of Food on Oxycodone Pharmacokinetics Following Oral 40 Mg Doses of PF-00345439 Formulation K and to Estimate Its Relative Bioavailability of Oxycodone Compared to PF-003454390 Formulation X in the Fasted State 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 [AUC (0 - 8)]
研究概览
简要总结
To estimate the effects of food on oxycodone pharmacokinetics after administration of 40 mg doses of PF-00345439 Formulation K and to estimate its relative bioavailability compared to PF-00345439 Formulation X in the fasted state in healthy volunteers
详细描述
This study will estimate the effect of food (standard high-fat breakfast) on the pharmacokineticsand relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF-00345439 Formulation K in healthy volunteers.
Additionally, the study will estimate the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of the test PF-00345439 Formulation K compared with the reference PF-00345439 Formulation X under fasted conditions in healthy volunteers and assess the single-dose safety and tolerability of oxycodone in PF-00345439 formulations in healthy volunteers when administered under a naltrexone block.
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
- 18 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 18 and 55 years of age (inclusive).
排除标准
- •Evidence or history of clinically significant disease
- •Positive urine drug test
研究组 & 干预措施
Treatment A
Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
干预措施: Oxycodone (Drug)
Treatment B
Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
干预措施: Oxycodone (Drug)
Treatment C
Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
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 [AUC (0 - 8)]
时间窗: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Maximum Observed Plasma Concentration (Cmax)
时间窗: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose
次要结局
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose)
- Concentration at time 24 hours (C24) of oxycodone, as data permit.(0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose)
- Plasma Decay Half-Life (t1/2)(0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose)