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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Abbott
• Treatments: Acetaminophen; Acetaminophen, hydrocodone drug combination; Ethanol; Hydrocodone; Oxycodone

Criteria

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