At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Oxycodone Tamper Resistant +1 moredrug
Likely dose
Oxycodone Tamper Resistant 10mgfrom 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 Fasted State Pharmacokinetics of Oxycodone From Oxycodone Tamper Resistant (OTR) Tablet 10 mg and OXYCONTIN® Tablet 10 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 24 participants across 1 site.
Detailed Summary
This is an open-label, single Dose, randomised, cross-over study to confirm the bioequivalence (BE) of OTR tablet 10 mg and OXYCONTIN tablet 10 mg in a fasted state in Chinese subjects with chronic pain
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain
CountriesChina
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartFeb 2017
Primary CompletionJul 2017
Study CompletionSep 2017
First PostedJan 2018
TodayJul 2026
First PostedJan 18, 2018
Enrollment StartFeb 1, 2017
Primary CompletionJul 24, 2017
Study CompletionSep 7, 2017
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.5 years ago
Interventions
Oxycodone Tamper Resistantdrug
Orally administered Oxycodone Tamper Resistant 10mg
OXYCONTIN®drug
Orally administered OXYCONTIN® Tablet 10 mg