NCT00429468

Brief Summary

The purpose of this research study is to determine if varying strengths of ethanol affect the drug level and safety profile of Vicodin® CR.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2007

Completed
Last Updated

October 26, 2007

Status Verified

October 1, 2007

First QC Date

January 29, 2007

Last Update Submit

October 24, 2007

Conditions

Drug Interactions

Outcome Measures

Primary Outcomes (2)

  • Standard pharmacokinetic assessments

  • statistical, clinical and laboratory procedures

Interventions

Vicodin® CR (extended-release hydrocodone/acetaminophen)DRUG

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Toronto, Ontario, M5V 2T3, Canada

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Rita Jain, MD

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 29, 2007

First Posted

January 31, 2007

Study Start

January 1, 2007

Last Updated

October 26, 2007

Record last verified: 2007-10

Locations

CA(1)