NCT01101191

A Study to Determine the Fasting 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 Fasting Bioequivalence of Oxycodone Tamper Resistant (OTR) 80-mg Tablets to OxyContin® 80-mg Tablets

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (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 (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fasted 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

Interventions

Type	Name	Description
DRUG	Reformulated OXY (oxycodone HCl)	Reformulated OXY 80-mg tablet x 1 dose taken without food.
DRUG	Original OxyContin® (OXY) (oxycodone HCl)	Original OxyContin® (OXY) 80-mg tablet x 1 dose taken without food.

Timeline

• Start date: 2007-08-01
• Primary completion: 2007-10-01
• Completion: 2008-01-01
• First posted: 2010-04-09
• Last updated: 2010-05-25
• Results posted: 2010-05-11

Locations

1 site across 1 country: United States