Effects of Food on Oxycodone Pharmacokinetics in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy

In brief

To estimate the effect of food on the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF 00345439 Formulation K taken whole or after chewing in healthy volunteers. We have described below the two cohorts each with two arms in this crossover study by listing them as four Arms/Groups in order to capture the differences between the cohorts prior to the crossover and after the crossover. 14 participants are planned for the first cohort and 18 participants are planned for the second cohort.

Key facts

Study ID

NCT02117583

Run by

Pain Therapeutics

People needed

34

Starts

2014-04-01

Expected to finish

2014-08-01

Last updated by the study team

2016-04-04

Who can join

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

You may qualify if…

• Healthy male and/or female subjects between 18 and 55 years of age

You may not qualify if…

• Evidence or history of clinically significant disease.
• Positive urine drug test

Where it is running

• Pfizer Investigational Site — Overland Park, Kansas, United States
• Pfizer Investigational Site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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