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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT02880475•Mundipharma (China) Pharmaceutical Co. Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adult Chinese patients with moderate to severe chronic non-malignant pain.
•2. Male and female subjects with age range 18 to 65 years (including 18 and 65), body weight ≥ 45kg and BMI range 18 to 30 (including 18 and 30).
•3. Patients who should rate their pain (Pain Intensity Scale -"average pain" over the last 24 hours) as ≥4 on 0-10 scale.
•4. Patients, who are able to read, understand and sign written informed consent prior to study participation and are willing to follow the protocol requirements.
•5. Females of childbearing potential and less than one year post-menopausal must have a negative serum pregnancy test during screening visit and at check-in and be non-lactating. In addition, they must be willing to use adequate and reliable contraception throughout the study. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectables, combined oral contraceptives, some IUDs (intrauterine Device, hormonal), sexual abstinence or vasectomised partner.

Exclusion Criteria

•1. Females who are pregnant (positive β-human chorionic gonadotrophin \[HCG\] test) or lactating.
•2. Use of opioid or opioid antagonist-containing medication in the 30 days before the start of the study.
•3. Known sensitivity to oxycodone, naloxone, or related compounds.
•4. Subjects with clinically unstable respiratory disease, dysfunction of the biliary tract, thyroid disease, adrenal cortical insufficiency, prostatic hypertrophy requiring intervention (medication or surgical) or renal artery stenosis, or any other medical condition, that, in the opinion of the investigator or the sub-investigator, precludes entry into this study.
•5. Subject who have a past (within 5 years) history of malignant neoplasm including leukemia and lymphoma.
•6. The electrocardiogram examination results are abnormal, in the opinion of the investigator or the sub-investigator, and are clinical significance.
•7. Subjects with abnormal liver function (values exceed the upper limit of normal for AST, ALT or total bilirubin during the Screening Period) or abnormal renal function (values exceed the upper limit of normal for serum creatinine during the Screening Period).
•8. Patients with a contraindication to the study medication.
•9. Subjects who have a psychiatric disorder such that participation in the study may, in the opinion of the investigator or the sub-investigator, pose an unacceptable risk to the subject.
•10. Subjects who have a current or past (within 5 years) history of substance or alcohol abuse, or subjects who give a positive result in drug abuse test during the Screening Period, or subjects who, in the opinion of the investigator or the sub-investigator, have demonstrated addictive or substance abuse behaviors.
+10 more criteria

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

June 1, 2014

Primary Completion Date

June 1, 2015

Completion Date

July 10, 2015

Last Updated

July 17, 2019

Enrollment

ACTUAL participants

Conditions

Chronic Pain

Interventions

OXN PR tablet

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 17, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

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