Drug Interactions Clinical Trial
Official title:
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
| NCT number | NCT00429468 |
| Other study ID # | M06-835 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | January 29, 2007 |
| Last updated | October 24, 2007 |
| Start date | January 2007 |
| Verified date | October 2007 |
| Source | Abbott |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this research study is to determine if varying strengths of ethanol affect the drug level and safety profile of Vicodin® CR.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 19 Years to 55 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Abbott |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Standard pharmacokinetic assessments | |||
| Primary | statistical, clinical and laboratory procedures |
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