NCT02165930已完成1 期
An Open Label, Single Dose, Randomized, Two Way Crossover Study to Estimate Oxycodone Relative Bioavailability in Healthy Volunteers Following Administration of PF 00345439 Formulation K 40 Mg Under Fasting Conditions With 40% Ethanol Compared With Water
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 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 Bioavailability Of 40 Mg Doses Of Pf-00345439 Formulation K Under Fasting Conditions with 40% Ethanol Compared with Water in Healthy Volunteers
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 volunteers
- •History of moderate alcohol consumption
- •Total body weight exceeding 64 kg
排除标准
- •Evidence or history of clinically significant disease.
- •Positive urine drug test
- •History of alcoholism or heavy alcohol consumption
研究组 & 干预措施
Treatment B
Experimental
干预措施: Naltrexone (Drug)
Treatment B
Experimental
干预措施: Oxycodone (Drug)
Treatment A
Experimental
干预措施: Naltrexone (Drug)
Treatment A
Experimental
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
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
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)
- Concentration at time 24 hours (C24)(0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48)
- Plasma Decay Half-Life (t1/2)(0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48)
研究者
研究点 (1)
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