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| Sponsored by: |
Abbott |
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00429468 |
Purpose
The purpose of this research study is to determine if varying strengths of ethanol affect the drug level and safety profile of Vicodin® CR.
| Condition | Intervention | Phase |
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Drug Interactions |
Drug: Vicodin® CR (extended-release hydrocodone/acetaminophen) |
Phase I |
| Drug Information available for: | Acetaminophen Ethanol Hydrocodone Hydrocodone bitartrate Vicodin |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study |
| 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 |
Eligibility
| Ages Eligible for Study: | 19 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | M06-835 |
| First Received: | January 29, 2007 |
| Last Updated: | October 24, 2007 |
| ClinicalTrials.gov Identifier: | NCT00429468 |
| Health Authority: | United States: Food and Drug Administration |
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