OXN PR Tablet 5/2.5 mg and20/10 mg PK Study in Chinese Moderate to Severe Chronic Non-malignant Patients
CompletedPhase 1NCT02880475
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
- Official title
- 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
- Conditions
- Interventions
- Drug: OXN PR tablet
- Sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
- Start date
- 2014-06-01
- Primary completion
- 2015-06-01
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- China
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 s…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02880475