At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 92 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 Fasting Bioequivalence of Oxycodone Tamper Resistant (OTR) 40-mg Tablets to OxyContin® 40-mg Tablets
In Brief
A Phase 1 clinical trial evaluating Reformulated OXY (oxycodone HCl) and Original OxyContin® (OXY) (oxycodone HCl) for Healthy. Completed, enrolled 92 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (40 mg) relative to the original OxyContin® (OXY) formulation (40 mg) in the fasted state.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2007
Primary CompletionApr 2007
Study CompletionJul 2007
First PostedApr 2010
TodayJul 2026
First PostedApr 9, 2010
Enrollment StartFeb 1, 2007
Primary CompletionApr 1, 2007
Study CompletionJul 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.2 years ago
Interventions
Reformulated OXY (oxycodone HCl)drug
Reformulated OXY 40-mg tablet x 1 dose taken without food
Original OxyContin® (OXY) (oxycodone HCl)drug
Original OxyContin® (OXY) 40-mg tablet x 1 dose taken without food