NCT02880475

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

It will be conducted to assess the pharmacokinetics of OXN 5/2.5 and OXN 20/10 tablets. Subjects will be allocated to a sequence of two strength group in accordance with a random allocation schedule (RAS) in a 1:1 ratio. Subjects will attend a screening visit within 14 days of the first (OXN) dosing day (Day 1). Eligible subjects will then check into the study unit on the day before OXN dosing (Day -2). Subjects will be administered their OXN dose the next 2 morning (Day 1), following an overnight fast.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DRUG	OXN PR tablet	Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-06-01
• Completion: 2015-07-10
• First posted: 2016-08-26
• Last updated: 2019-07-17
• Results posted: 2019-07-17

Locations

1 site across 1 country: China