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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Ethanol; Oxycodone

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