At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 42 enrolled
Drug / intervention
Oxycodone Tamper Resistant +1 moredrug
Likely dose
Oxycodone Tamper Resistant 40mgfrom 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.
An Open-label, Single Dose, Randomised, Cross-over Study to Determine the Fed State Pharmacokinetics of Oxycodone From Oxycodone Tamper Resistant (OTR) Tablet 40 mg and OXYCONTIN® Tablet 40 mg in Chinese Subjects With Chronic Pain
In Brief
A Phase 1 clinical trial evaluating Oxycodone Tamper Resistant and OxyContin® for Chronic Pain. Completed, enrolled 42 participants across 1 site.
Detailed Summary
An open-label, single dose, randomized, cross-over study to confirm the bioequivalence (BE) of OTR tablet 40 mg and OXYCONTIN tablet 40 mg in a fed state in Chinese subjects with chronic pain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain
CountriesChina
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartMar 2017
Primary CompletionSep 2017
Study CompletionNov 2017
First PostedJan 2018
TodayJul 2026
First PostedJan 12, 2018
Enrollment StartMar 16, 2017
Primary CompletionSep 5, 2017
Study CompletionNov 6, 2017
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.5 years ago
Interventions
Oxycodone Tamper Resistantdrug
Orally taking Oxycodone Tamper Resistant 40mg in fed state
OxyContin®drug
Orally taking OXYCONTIN® 40mg in fed state