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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

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ClinicalTrials.gov Identifier: NCT01677039
Recruitment Status : Completed
First Posted : August 31, 2012
Last Update Posted : December 11, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Healthy Drug: Test formulation administered with water Drug: Test formulation administered with 20% ethanol Drug: Test formulation administered with 40% ethanol Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : September 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Treatment A 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
Experimental: Treatment B 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
Experimental: Treatment C 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



Primary Outcome Measures :
  1. Maximum observed oxycodone concentration in plasma (Cmax) [ Time Frame: hours after dosing ]
  2. Area under the oxycodone concentration versus time curve (AUC) [ Time Frame: hours after dosing ]

Secondary Outcome Measures :
  1. Time-to-peak concentration (Tmax) [ Time Frame: hours after dosing ]
  2. half-life of drug [ Time Frame: hours after dosing ]
  3. Vital signs and adverse events [ Time Frame: hours after dosing ]


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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677039


Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01677039     History of Changes
Other Study ID Numbers: B4531004
First Posted: August 31, 2012    Key Record Dates
Last Update Posted: December 11, 2012
Last Verified: December 2012

Keywords provided by Pfizer:
Bioavailability
oxycodone
ethanol interaction
healthy volunteers

Additional relevant MeSH terms:
Oxycodone
Ethanol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Infective Agents, Local
Anti-Infective Agents