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

Completed · Phase 1

Conditions studied: Healthy

In brief

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).

Key facts

Study ID

NCT01677039

Run by

Pfizer

People needed

19

Starts

2012-09-01

Expected to finish

2012-12-01

Last updated by the study team

2012-12-11

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• healthy volunteers
• history of moderate alcohol consumption
• total body weight exceeding 64 kg

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.