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

NCT02880475 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-07-17

Study results available
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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.

Conditions

Interventions

DRUG

OXN PR tablet

Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg

Sponsors & Collaborators

  • Mundipharma (China) Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Victoria YU · Mundipharma (China) Pharmaceutical Co. Ltd

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02880475 on ClinicalTrials.gov