Pharmacokinetic (PK) Study of OxyNorm Injections in Chinese Patient

Mundipharma

Status and phase

Completed

Phase 1

Conditions

Pain

Treatments

Drug: Oxycodone (OxyNorm®) Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT01482936

OXYI09-CN-101

Details and patient eligibility

About

This is a single center, open label, randomized, parallel group single dose intravenous (i.v.) administration study. The subjects will be randomized to receive a single dose of OxyNorm® 2.5, 5, and 10mg.

Full description

After up to 7 days screening period, Eligible Patients will be randomized to 1 of 3 groups, and begin treatment with single dose of OxyNorm® 2.5,5, and 10mg.

Enrollment

44 patients

Sex

All

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with tumor pain / postoperative pain, or subjects with pain caused by other diseases;
Patients aged >30 to ≤ 60 years;
Body weight ≥ 45kg, and BMI range ≥19, <24;
Karnofsky score ≥ 70;
Expected survival is above 3 months;
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 pulmonary, or chronic bronchial asthma;
Patient 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 ant-HIV or syphilis antibody test result;
Urine screening before study is positive for the 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 two months of study entry.
Patients who are currently taking opioids.