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OpenTrials
Completed

NCT Number: NCT00429468

A 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.

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Key information

Conditions

Drug Interactions

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Toronto, Ontario, M5V 2T3, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vicodin® CR (extended-release hydrocodone/acetaminophen)

Drug

Primary outcomes

  1. Standard pharmacokinetic assessments

  2. statistical, clinical and laboratory procedures

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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

Important dates

Study start
2007
First posted
Jan 31, 2007
Registry last updated
Oct 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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