- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00429468
A Study to Evaluate the Interaction Between Vicodin® CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers
October 24, 2007 updated by: Abbott
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
25
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5V 2T3
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Standard pharmacokinetic assessments
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statistical, clinical and laboratory procedures
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Study Registration Dates
First Submitted
January 29, 2007
First Submitted That Met QC Criteria
January 29, 2007
First Posted (Estimate)
January 31, 2007
Study Record Updates
Last Update Posted (Estimate)
October 26, 2007
Last Update Submitted That Met QC Criteria
October 24, 2007
Last Verified
October 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antipyretics
- Analgesics, Opioid
- Narcotics
- Respiratory System Agents
- Antitussive Agents
- Acetaminophen
- Hydrocodone
- Acetaminophen, hydrocodone drug combination
Other Study ID Numbers
- M06-835
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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