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

NCT01100086 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2010-05-25

Study results available
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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 fasted state.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Reformulated OXY (oxycodone HCl)

Reformulated OXY 10-mg tablet x 1 dose taken without food

DRUG

Original OxyContin® (OXY) (oxycodone HCl)

Original OxyContin® (OXY) 10-mg tablet 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
2007-01-31
Primary Completion
2007-03-31
Completion
2007-06-30

Countries

  • United States

Study Locations

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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 NCT01100086 on ClinicalTrials.gov