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A Randomized, Two-way, Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01677065
Collaborator
(none)
14
Enrollment
1
Location
30
Duration (Days)
14.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine whether the bioavailability of the controlled-release test formulation is at least as high as that for the commercial reference drug.

Condition or Disease Intervention/Treatment Phase
  • Drug: Oxycodone controlled-release test formulation
  • Drug: Immediate-release reference drug

Detailed Description

Serial sampling of venous blood

Study Design

Study Type:
Observational
Actual Enrollment :
14 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
An Open-label, Single-dose, Randomized, Two-way Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
Oct 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Treatment A

Controlled release oxycodone test formulation 40 mg

Drug: Oxycodone controlled-release test formulation
single dose administration of test formulation under fasted conditions
Other Names:
  • ALO-02

    		•
    Treatment B

    Immediate release oxycodone reference drug 20 mg

    Drug: Immediate-release reference drug
    single dose administration of reference drug under fasted conditions
    Other Names:
  • Roxicodone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. pharmacokinetic endpoints - area under the concentration curve (AUC) [0-48 hr]

    Secondary Outcome Measures

    1. Peak concentration (Cmax) and time to peak concentration (Tmax) [0-48 hr]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • healthy volunteers, greater than 50 kg, able and willing to sign informed consent
    Exclusion Criteria:
    • Evidence of significant illness, condition affecting drug absorption, history of sleep apnea, and allergy to opioid drugs

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site New Haven Connecticut United States 06511

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT01677065
    Other Study ID Numbers:
    • B4531007
    • ALO-02 Bioavailability Study
    First Posted:
    Aug 31, 2012
    Last Update Posted:
    Sep 28, 2018
    Last Verified:
    Sep 1, 2018
    Keywords provided by Pfizer
    Bioavailability
    Oxycodone
    Healthy Volunteers
    Additional relevant MeSH terms:
    Oxycodone

    Study Results

    No Results Posted as of Sep 28, 2018