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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Test formulation administered with 40% ethanol; Drug: Test formulation administered with 20% ethanol; Drug: Test formulation administered with water

Study type: Interventional

Funder types: Industry

Identifiers

NCT01677039

B4531004

Details and patient eligibility

About

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).

Enrollment: 19 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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19 participants in 3 patient groups

Treatment A

Active Comparator group

Treatment:

Drug: Test formulation administered with water

Treatment B

Experimental group

Treatment:

Drug: Test formulation administered with 20% ethanol

Treatment C

Experimental group

Treatment:

Drug: Test formulation administered with 40% ethanol