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Completed

NCT Number: NCT01677039

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

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).

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Key information

Conditions

Healthy

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test formulation administered with water

Drug

single dose of 20 mg of test formulation with 240 mL of water

Other names: ALO-02 20 mg

Test formulation administered with 20% ethanol

Drug

single dose of 20 mg of test formulation with 240 mL of 20% ethanol in water

Other names: ALO-02 20 mg

Test formulation administered with 40% ethanol

Drug

single dose of 20 mg of test formulation with 240 mL of 40% ethanol

Other names: ALO-02 20 mg

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 31, 2012
Registry last updated
Dec 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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