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

Phase 1

Completed

• Conditions: Drug Interactions

• Registration Number: NCT00429468
• Lead Sponsor: Abbott

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-29
• Study First Submitted QC: 2007-01-29
• Study First Posted: 2007-01-31
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-24
• Last Update Posted: 2007-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Standard pharmacokinetic assessments
statistical, clinical and laboratory procedures