A Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled, 4-Way Crossover Study to Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen 6 × 10/325 mg Tablets Compared to NORCO® 6 × 10/325 mg Tablets and Placebo in Non-Dependent, Recreational Opioid Users When Administered Orally Under Fed and Fasted Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Drug Liking
研究概览
简要总结
Evaluation of abuse potential in recreational abusers of Hydrocodone Bitartrate and Acetaminophen versus NORCO®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 or female subjects 18 to 55 years of age.
- •Opioid users who have used opioids for recreational purposes and or is an avid opioid user.
排除标准
- •Substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years.
- •Heavy smoker and/or is unable to abstain from smoking or unable to abstain from the use of prohibited nicotine containing products for at least 6 hours during the in-clinic periods.
- •Difficulty swallowing large number of pills.
- •Subjects who have had a tattoo or body piercing.
研究组 & 干预措施
Reference
Single dose
干预措施: Placebo (Drug)
Hydrocodon bitartrate-acetaminophen arm 1
Single dose
干预措施: Reference (Drug)
Hydrocodon bitartrate-acetaminophen arm 2
Single dose
干预措施: Placebo (Drug)
Placebo
Single dose
干预措施: Placebo (Drug)
Placebo
Single dose
干预措施: Reference (Drug)
Hydrocodon bitartrate-acetaminophen arm 1
Single dose
干预措施: Placebo (Drug)
Hydrocodon bitartrate-acetaminophen arm 2
Single dose
干预措施: Reference (Drug)
Reference
Single dose
干预措施: Hydrocodon bitartrate-acetaminophen arm 1 (Drug)
Reference
Single dose
干预措施: Hydrocodon bitartrate-acetaminophen arm 2 (Drug)
Reference
Single dose
干预措施: Reference (Drug)
Placebo
Single dose
干预措施: Hydrocodon bitartrate-acetaminophen arm 2 (Drug)
Hydrocodon bitartrate-acetaminophen arm 2
Single dose
干预措施: Hydrocodon bitartrate-acetaminophen arm 1 (Drug)
Hydrocodon bitartrate-acetaminophen arm 2
Single dose
干预措施: Hydrocodon bitartrate-acetaminophen arm 2 (Drug)
Placebo
Single dose
干预措施: Hydrocodon bitartrate-acetaminophen arm 1 (Drug)
Hydrocodon bitartrate-acetaminophen arm 1
Single dose
干预措施: Hydrocodon bitartrate-acetaminophen arm 1 (Drug)
Hydrocodon bitartrate-acetaminophen arm 1
Single dose
干预措施: Hydrocodon bitartrate-acetaminophen arm 2 (Drug)
结局指标
主要结局
Drug Liking
时间窗: 15 weeks
Visual analog scale on score from 0 to 100
次要结局
未报告次要终点