A Study to Evaluate the Interaction Between Vicodin® CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers

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

The purpose of this research study is to determine if varying strengths of ethanol affect the drug level and safety profile of Vicodin® CR.

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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