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

Pfizer19 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Test formulation administered with waterDRUG

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

Test formulation administered with 20% ethanolDRUG

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

Test formulation administered with 40% ethanolDRUG

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States