CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 84 enrolled
Drug / intervention
Reformulated OXY (oxycodone HCl) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01101191
NCT01101191Phase 1Completed
CompareCT.gov

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

Purdue Pharma LP·interventional·Posted Apr 9, 2010·Updated May 25, 2010

In Brief

A Phase 1 clinical trial evaluating Reformulated OXY (oxycodone HCl) and Original OxyContin® (OXY) (oxycodone HCl) for Healthy. Completed, enrolled 84 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 9, 2010
Enrollment StartAug 1, 2007
Primary CompletionOct 1, 2007
Study CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.2 years ago

Interventions

Reformulated OXY (oxycodone HCl)drug

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

Original OxyContin® (OXY) (oxycodone HCl)drug

Original OxyContin® (OXY) 80-mg tablet x 1 dose taken without food.