OXN PR Tablet 5/2.5 mg and20/10 mg PK Study in Chinese Moderate to Severe Chronic Non-malignant Patients
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: OXN PR tablet
Intervention description: Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Moderate to severe chronic non-malignant pain

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.
    

Eligibility criteria:

        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.

         11. Subjects with uncontrolled seizures or convulsive disorder.

         12. Subjects who will receive any interventional therapy (surgery, paracentesis,etc) for
             arthritis during the study period.

         13. History of or any current conditions that might have interfered with drug absorption,
             distribution, metabolism or excretion.

         14. Any history of frequent nausea or emesis regardless of aetiology.

         15. Participation in any clinical drug study during the 3 months preceding the initial
             dose in this study.

         16. Use of any medication including vitamins, herbal and/or mineral supplements during the
             course of the study, other than Vitamin D, calcium supplements and continued use by
             females of contraceptive medication or HRT.

         17. Consumption of alcoholic beverages within 48 hours before study drug administration,
             and refusal to abstain from alcohol until at least 48 hours after the last study drug
             administration.

         18. Blood or blood products donated within 90 days prior to study drug administration or
             anytime during the study, except as required by this protocol.

         19. Positive results of urine drug screen(for opioids, barbiturates, amphetamines, cocaine
             metabolites, methadone, diazepam and cannabinoids), alcohol breath test, hepatitis B
             surface antigen (HBsAg), hepatitis C virus antibody (Ab), human immunodeficiency virus
             (HIV) test or qualitative syphilis tests.

         20. Patients with moderate to severe hypohemia (HGB<90g/L during the screening).