A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers

Completed · Phase 1

Conditions studied: Analgesia, Acute Pain, Chronic Pain, Narcotic Abuse, Opioid-related Disorders

In brief

This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 5-dosing period study to characterize the pharmacokinetics (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of oxycodone. The study will take place over approximately two and a half months and will consist of three phases: a screening visit to determine eligibility for the study, a 5-dosing period treatment phase, and an end-of-study visit.

Key facts

Study ID

NCT01530542

Run by

Pfizer

People needed

35

Starts

2010-07-01

Expected to finish

2010-09-01

Last updated by the study team

2012-02-24

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male or female subjects between 18 and 55 years of age (inclusive)

You may not qualify if…

• Evidence or history of clinically significant disease;
• History of obstructive sleep apnea;
• Positive urine drug test.

Where it is running

• Pfizer Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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