drugset / Trial / NCT01456507

Healthy Volunteers Study to Estimate the Effects of Food on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Formulation of Oxycodone With Sequestered Naltrexone

NCT01456507

Phase 1 Completed 24 enrolled Pfizer
RandomizedCrossoverOpen-labelOther

Summary

The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered naltrexone 4.8 mg.

Timeline

Start
2011-10
Primary completion
2012-01
Completion
2012-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Naltrexone Small molecule 4.8 mg Oral
Subject Oxycodone Other / unclassified 40 mg Oral

Indications

No indication recorded.