drugset / Trial / NCT00853268

Fed Study of Controlled-Release Oxycodone Hydrochloride 40 mg Tablets and OxyContin® 40 mg Tablets

NCT00853268

Phase 1 Completed 34 enrolled Mallinckrodt
RandomizedParallel-groupOpen-label

Summary

The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt controlled-release test tablet formulation of oxycodone 40 mg compared to an equivalent oral dose of a commercially available controlled-release tablet of oxycodone (OxyContin® 40 mg, Purdue Pharma L.P.) in a test group of healthy subjects under fed conditions.

Timeline

Start
2005-04
Primary completion
2005-04
Completion
2005-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Oxycodone Other / unclassified 40 mg Oral

Indications

No indication recorded.