A Randomized, Two-way, Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers

Completed

Conditions studied: Healthy

In brief

To determine whether the bioavailability of the controlled-release test formulation is at least as high as that for the commercial reference drug.

Key facts

Study ID

NCT01677065

Run by

Pfizer

People needed

14

Starts

2012-09-01

Expected to finish

2012-10-01

Last updated by the study team

2018-09-28

Who can join

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

You may qualify if…

• healthy volunteers, greater than 50 kg, able and willing to sign informed consent

You may not qualify if…

• Evidence of significant illness, condition affecting drug absorption, history of sleep apnea, and allergy to opioid drugs

Where it is running

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

Full record on ClinicalTrials.gov

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