At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
OXN PR tabletdrug
Likely dose
OXN PR tablet 2.5 mgfrom 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, Randomized, Single-dose, Parallel Group Study to Investigate the Pharmacokinetics of Oxycodone and Naloxone From OXN 5/2.5 and OXN 20/10 in Chinese Patients With Moderate to Severe Chronic Non-malignant Pain
In Brief
A Phase 1 clinical trial evaluating OXN PR tablet for Chronic Pain. Completed, enrolled 30 participants across 1 site.
Detailed Summary
This is an open-label, randomized, single-dose, parallel group study. The objectives of this study are to assess pharmacokinetics of oxycodone and naloxone from oxycodone/naloxone (OXN) prolonged release (PR) tablet 5/2.5 mg (OXN 5/2.5) and 20/10 mg (OXN 20/10) in Chinese patients with moderate to severe chronic non-malignant pain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain
CountriesChina
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJun 2014
Primary CompletionJun 2015
Study CompletionJul 2015
First PostedAug 2016
TodayJul 2026
First PostedAug 26, 2016
Enrollment StartJun 1, 2014
Primary CompletionJun 1, 2015
Study CompletionJul 10, 2015
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 9.8 years ago
Interventions
OXN PR tabletdrug
Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg