Status:
COMPLETED
A Study to Evaluate the Interaction Between Vicodin® CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers
Lead Sponsor:
Abbott
Conditions:
Drug Interactions
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00429468
Start Date
January 1 2007
Last Update
October 26 2007
Active Locations (1)
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1
Toronto, Ontario, Canada, M5V 2T3