An Open-Label, Single-Dose, Randomized, Three-Way Crossover Study in Healthy Volunteers to Estimate the Effects of Food and of Sprinkling ALO-02 Pellets on Applesauce on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Pellets-in-Capsule Formulation of Oxycodone 40 Mg With Sequestered Naltrexone 4.8 Mg
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area Under the Curve (AUC) to time infinity (inf) of oxycodone
研究概览
简要总结
The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered naltrexone 4.8 mg.
详细描述
Bioavailability
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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 the ages of 18 and 55 years, inclusive
排除标准
- •Evidence or history of clinically significant diseases
研究组 & 干预措施
A
1×40 mg ALO-02 capsule administered with 240 mL of water under fasting conditions.
干预措施: ALO-02 (Oxycodone Naltrexone) (Drug)
B
1×40 mg ALO-02 capsule administered with 240 mL of water under fed conditions (standard high fat breakfast).
干预措施: ALO-02 (Oxycodone Naltrexone) (Drug)
C
1×40 mg ALO-02 with the ALO-02 pellets sprinkled approximately on one table spoon of applesauce, and administered with 240 mL of water under fasting conditions.
干预措施: ALO-02 (Oxycodone Naltrexone) (Drug)
结局指标
主要结局
Area Under the Curve (AUC) to time infinity (inf) of oxycodone
时间窗: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Area Under the Curve (AUC) to last quantifiable concentration (last) of oxycodone
时间窗: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Maximum Plasma Concentration (Cmax) of oxycodone
时间窗: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
次要结局
- Adverse events, vital signs, pulse oximetry, and safety laboratory parameters.(over 120 hours)
- C24, Tmax (time at maximum concentration) and half-life of oxycodone, as data permit.(predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose)
- AUClast, AUCinf, and Cmax of naltrexone and 6-beta-naltrexol, as data permit(predose, 1,2,4,8,12,24,48,120 hours post-dose)