At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 38 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 Fasted 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 38 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 40 mg and OXYCONTIN tablet 40 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
201820192020202120222023202420252026
Enrollment StartJun 2017
Primary CompletionOct 2017
First PostedJan 2018
Study CompletionMar 2018
TodayJul 2026
First PostedJan 12, 2018
Enrollment StartJun 30, 2017
Primary CompletionOct 15, 2017
Study CompletionMar 20, 2018
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 8.5 years ago
Interventions
Oxycodone Tamper Resistantdrug
Orally taking Oxycodone Tamper Resistant 40mg in fast state
OXYCONTIN®drug
Orally taking OXYCONTIN® 40mg in fast state