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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
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 19
Study Start Date: September 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01677039     History of Changes
Other Study ID Numbers: B4531004
Study First Received: August 29, 2012
Last Updated: December 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Bioavailability
oxycodone
ethanol interaction
healthy volunteers

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

ClinicalTrials.gov processed this record on May 19, 2013