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Study to Determine the Effects of Co-Administration of Alcohol on the Absorption of Oxycodone From a Proprietary Controlled-Release Formulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01677039
First received: August 29, 2012
Last updated: December 10, 2012
Last verified: December 2012
History of Changes

August 29, 2012
December 10, 2012
September 2012
December 2012   (final data collection date for primary outcome measure)
  • Maximum observed oxycodone concentration in plasma (Cmax) [ Time Frame: hours after dosing ] [ Designated as safety issue: No ]
  • Area under the oxycodone concentration versus time curve (AUC) [ Time Frame: hours after dosing ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01677039 on ClinicalTrials.gov Archive Site
  • Time-to-peak concentration (Tmax) [ Time Frame: hours after dosing ] [ Designated as safety issue: No ]
  • half-life of drug [ Time Frame: hours after dosing ] [ Designated as safety issue: No ]
  • Vital signs and adverse events [ Time Frame: hours after dosing ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Determine the Effects of Co-Administration of Alcohol on the Absorption of Oxycodone From a Proprietary Controlled-Release Formulation
An Open-label, Single-dose, Randomized, Three-way Crossover Study to Estimate the Effects of Ethanol 20% and 40% on the Bioavailability a Controlled Release Formulation of Oxycodone 20 Mg With Sequestered Naltrexone 2.4 Mg in Healthy Volunteers

The study is designed to test whether or not the rate and extent of absorption of oxycodone from a proprietary controlled-release formulation is significantly affected by co-administration of alcohol compared with controlled conditions (when the formulation is administered with water). The primary pharmacokinetic parameters are the peak concentration of oxycodone (Cmax) and the overall exposure level of oxycodone as represented by the area under the plasma concentration-time curve (AUC).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • Drug: Test formulation administered with water
    single dose of 20 mg of test formulation with 240 mL of water
    Other Name: ALO-02 20 mg
  • Drug: Test formulation administered with 20% ethanol
    single dose of 20 mg of test formulation with 240 mL of 20% ethanol in water
    Other Name: ALO-02 20 mg
  • Drug: Test formulation administered with 40% ethanol
    single dose of 20 mg of test formulation with 240 mL of 40% ethanol
    Other Name: ALO-02 20 mg
  • Active Comparator: Treatment A
    Intervention: Drug: Test formulation administered with water
  • Experimental: Treatment B
    Intervention: Drug: Test formulation administered with 20% ethanol
  • Experimental: Treatment C
    Intervention: Drug: Test formulation administered with 40% ethanol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy volunteers
  • history of moderate alcohol consumption
  • total body weight exceeding 64 kg

Exclusion Criteria:

  • history of clinically significant disease
  • history of sleep apnea
  • any condition affecting drug absorption
  • pregnant or nursing female subjects
  • history of allergy or hypersensitivity to either oxycodone or naltrexone
Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01677039
B4531004
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP