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).

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