Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT00429468
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
55 Years
Study:
NCT00429468
Study Brief:
Protocol Section:
NCT00429468