OxyNorm® Capsules (Immediate-Release) Pharmacokinetic (PK) Study
Condition: Pain
Intervention: Oxycodone hydrochloride
Intervention description: The subjects will be randomized to receive either a single dose of OxyNorm® Capsules 5, 10, 20mg, or multiple-dose OxyNorm® Capsules 10 mg for 13 times.
Intervention MeSH terms: Oxycodone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 30 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      A Single Dose PK Study of OxyNorm® immediate-release capsules 5, 10, and 20mg, and a
      multiple-dose PK Study of OxyNorm® immediate-release capsules 10mg in Chinese patients with
      pain.It will be a single center, open label, randomized, oral administration study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with pain, Multiple dose group should enroll the Patients with cancer pain;

          -  Patients aged >≥30 to ≤ 60 years;

          -  Body weight ≥ 45kg, and BMI range ≥19, <24;

          -  Karnofsky score ≥ 70;

          -  The results of liver function and kidney tests must meet the following criteria:
             ALT、AST is within the upper limit of normal value ranges by a factor 2, and TB、BUN、Cr
             is within the upper limit of normal value ranges by a factor 1.25;

          -  The electrocardiogram examination results are normal;

          -  Patients must have given a written informed consent prior to this trial, and have the
             capability to complete every required test.

        Exclusion Criteria:

          -  Have hypersensitivity history to any opioids;

          -  Have known hypersensitivity to any of compositions of the study drugs;

          -  Patients who are likely to have paralytic ileus or acute abdomen or to perform an
             operation on abdominal region；

          -  Patients with respiratory depression, cor pulmonale, or chronic bronchial asthma;

          -  Patients who are unable to stop taking monoamine oxidase inhibitor during this trial
             period or time lapses less than 2 weeks since drug withdrawal;

          -  Patients with hypercarbia;

          -  Patients with biliary tract diseases, pancreatitis, prostatic hypertrophy, or
             corticoadrenal insufficiency;

          -  Patients with alcoholism or drug abuse history;

          -  Positive anti-HIV or syphilis antibody test result;

          -  Patients who are pregnant, or lactating;

          -  Urine screening before study is positive for opioids, barbiturates, amphetamines,
             cocaine metabolites, methadone, diazepam and cannabinoids;

          -  Donated 400 mL or more of blood or blood products within 3 months prior to the start
             of the study, or donated 200 mL or more of blood or blood products within one month
             prior to the start of the study;

          -  Subjects who participated in a clinical research study within one month of study
             entry;

          -  Patients who are currently taking opioids.