NCT01101308

A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities

A Randomized, Open-Label, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fasting Bioequivalence of Oxycodone Tamper Resistant (OTR) 10-mg Tablets Manufactured at the Totowa, NJ Facility to Oxycodone Tamper Resistant (OTR) 10-mg Tablets Manufactured at the Wilson, NC Facility

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (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) manufactured at the Totowa, NJ facility relative to the formulation (10 mg) manufactured at the Wilson, NC facility 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 (Totowa) (oxycodone HCl)	Reformulated OXY 10-mg tablet (Totowa) x 1 dose taken in the fasted state.
DRUG	Reformulated OXY (Wilson) (oxycodone HCl)	Reformulated OXY 10-mg tablet (Wilson) x 1 dose taken in the fasted state.

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-08-01
• Completion: 2009-01-01
• First posted: 2010-04-09
• Last updated: 2010-05-25
• Results posted: 2010-05-11

Locations

1 site across 1 country: United States