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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Test formulation administered with water; Drug: Test formulation administered with 20% ethanol; Drug: Test formulation administered with 40% ethanol

• Registration Number: NCT01677039
• Lead Sponsor: Pfizer

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-29
• Study First Submitted QC: 2012-08-30
• Study First Posted: 2012-08-31
• Study Start: 2012-09
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-10
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	Test formulation administered with water	-
Treatment B	Test formulation administered with 20% ethanol	-
Treatment C	Test formulation administered with 40% ethanol	-

Primary Outcome Measures

Name	Time	Method
Maximum observed oxycodone concentration in plasma (Cmax)	hours after dosing
Area under the oxycodone concentration versus time curve (AUC)	hours after dosing

Secondary Outcome Measures

Name	Time	Method
Time-to-peak concentration (Tmax)	hours after dosing
half-life of drug	hours after dosing
Vital signs and adverse events	hours after dosing

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States