NCT00429468已完成1 期
A Single-Centre, Double-Blind, Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Interaction Between Vicodin® CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers
Abbott1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2007年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Standard pharmacokinetic assessments
研究概览
简要总结
The purpose of this research study is to determine if varying strengths of ethanol affect the drug level and safety profile of Vicodin® CR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females ages 19 to 55
- •If female, must be of non-child bearing potential or practicing birth control
- •Current alcohol users who are classified as moderate drinkers (defined as 7-21 drinks per week)
排除标准
- •Intolerance towards ethanol
- •Is allergic to or has a serious reaction to hydrocodone, other opioids, or acetaminophen
- •Significant GI narrowing or abnormality with a potential to inhibit GI motility or tablet transport
- •History of seizures or convulsions, head injury or other intracranial lesions, or a pre-existing increase in intracranial pressure
- •Has any clinically significant abnormalities on physical examination, ECG, or laboratory values
- •Treatment with any investigational drug within 30 days of administration of study drug in the Treatment Phase
结局指标
主要结局
Standard pharmacokinetic assessments
statistical, clinical and laboratory procedures
次要结局
未报告次要终点
研究者
研究点 (1)
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