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Completed Phase 1 Interventional Accepts healthy volunteers Results available

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

ClinicalTrials.gov ID: NCT01099709

Public ClinicalTrials.gov record NCT01099709. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 4:04 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01099709
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Purdue Pharma LP
Industry
Enrollment
85 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 50 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 2007 (Type not available)
Primary completion
Mar 2007 (Actual)
Completion
Aug 2007 (Actual)
Last update posted
May 6, 2010

2007

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Covance Clinical Research Unit Honolulu Hawaii 96813 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01099709, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 6, 2010 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01099709 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →