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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:
ClinicalTrials.gov Identifier:
NCT01677039
First Posted: August 31, 2012
Last Update Posted: December 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01677039     History of Changes
Other Study ID Numbers: B4531004
First Submitted: August 29, 2012
First Posted: August 31, 2012
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