drugset
drugset / Trial / NCT02880475

OXN PR Tablet 5/2.5 mg and20/10 mg PK Study in Chinese Moderate to Severe Chronic Non-malignant Patients

NCT02880475 ↗

Phase 1 Completed 30 enrolled Mundipharma (China) Pharmaceutical Co. Ltd
RandomizedParallel-groupOpen-labelOther

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.

Timeline

Start
2014-06-01
Primary completion
2015-06-01
Completion
2015-07-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Naloxone Small molecule 2.5 mg Oral
Subject Naloxone Small molecule 10 mg Oral
Subject Oxycodone Other / unclassified 5 mg Oral
Subject Oxycodone Other / unclassified 20 mg Oral

Indications

chronic pain syndrome