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

• 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
• 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
• 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

• Active Comparator: Treatment A
  
  Intervention: Drug: Test formulation administered with water
• Experimental: Treatment B
  
  Intervention: Drug: Test formulation administered with 20% ethanol
• Experimental: Treatment C
  
  Intervention: Drug: Test formulation administered with 40% ethanol

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