OxyNorm® Capsules (Immediate-Release) Pharmacokinetic (PK) Study

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd
• Treatments: Oxycodone

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.