MedTrace Logo

To Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities

NCT01101321 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2015-11-18

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured at the Wilson, NC facility in the fasted state.

Conditions

  • Healthy

Interventions

DRUG

Reformulated OXY (Totowa) (oxycodone HCl)

Reformulated OXY 80-mg tablet (Totowa) x 1 dose taken without food.

DRUG

Reformulated OXY (Wilson) (oxycodone HCl)

Reformulated OXY 80-mg tablet (Wilson) x 1 dose taken without food.

Sponsors & Collaborators

  • Purdue Pharma LP

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2008-08-31
Completion
2008-11-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01101321 on ClinicalTrials.gov