At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 55 enrolled
Drug / intervention
Reformulated OXY (Totowa) (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-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fasting Bioequivalence of Oxycodone Tamper Resistant (OTR) 10-mg Tablets Manufactured at the Totowa, NJ Facility to Oxycodone Tamper Resistant (OTR) 10-mg Tablets Manufactured at the Wilson, NC Facility
In Brief
A Phase 1 clinical trial evaluating Reformulated OXY (Totowa) (oxycodone HCl) and Reformulated OXY (Wilson) (oxycodone HCl) for Healthy. Completed, enrolled 55 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) manufactured at the Totowa, NJ facility relative to the formulation (10 mg) manufactured at the Wilson, NC facility in the fasted state.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2008
Primary CompletionAug 2008
Study CompletionJan 2009
First PostedApr 2010
TodayJul 2026
First PostedApr 9, 2010
Enrollment StartJul 1, 2008
Primary CompletionAug 1, 2008
Study CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.2 years ago
Interventions
Reformulated OXY (Totowa) (oxycodone HCl)drug
Reformulated OXY 10-mg tablet (Totowa) x 1 dose taken in the fasted state.
Reformulated OXY (Wilson) (oxycodone HCl)drug
Reformulated OXY 10-mg tablet (Wilson) x 1 dose taken in the fasted state.