NCT01099709

A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets

A Randomized, Open-Label, Single-Center, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fed Bioequivalence of Oxycodone Tamper Resistant (OTR) 10-mg Tablets to OxyContin® 10-mg Tablets

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) relative to the original OxyContin® (OXY) formulation (10 mg) in the fed state.

Detailed description

Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Reformulated OXY (oxycodone HCl)	Reformulated OXY 10-mg tablet x 1 dose taken with food.
DRUG	Original OxyContin® (OXY) (oxycodone HCl)	Original OxyContin® (OXY) 10-mg tablet x 1 dose taken with food.

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-03-01
• Completion: 2007-08-01
• First posted: 2010-04-07
• Last updated: 2010-05-06
• Results posted: 2010-05-06

Locations

1 site across 1 country: United States