At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 79 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.
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) 80-mg Tablets to OxyContin® 80-mg Tablets
In Brief
A Phase 1 clinical trial evaluating Reformulated OXY (oxycodone HCl) and Original OxyContin® (OXY) (oxycodone HCl) for Healthy. Completed, enrolled 79 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 fed state.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
Primary CompletionNov 2007
First PostedApr 2010
TodayJul 2026
First PostedApr 9, 2010
Enrollment StartAug 1, 2007
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 16.2 years ago
Interventions
Reformulated OXY (oxycodone HCl)drug
Reformulated OXY 80-mg tablet x 1 dose taken with food.
Original OxyContin® (OXY) (oxycodone HCl)drug
Original OxyContin® (OXY) 80-mg tablet x 1 dose taken with food.