NCT00853268

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

An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of a Controlled-Release Test Tablet Formulation of Oxycodone Hydrochloride (40 mg) Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (OxyContin® 40 mg, Purdue Pharma L.P.) in Normal Human Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Controlled-Release Oxycodone Hydrochloride 40 mg	Controlled-Release Oxycodone Hydrochloride 40 mg, single dose with food
DRUG	OxyContin® 40 mg tablet	OxyContin® 40 mg tablet, single dose with food

Timeline

• Start date: 2005-04-01
• Primary completion: 2005-04-01
• Completion: 2005-04-01
• First posted: 2009-03-02
• Last updated: 2016-09-09

Locations

1 site across 1 country: United States