Pharmacokinetic (PK) Study of OxyNorm Injections in Chinese Patient

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
A Single Dose PK Study of Oxycodone Hydrochloride Injection 2.5, 5, and 10mg in Chinese Patients With Cancer Pain or Post-operation Patients

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Oxycodone (OxyNorm®) Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxycodone (OxyNorm®) Injection<br>The subjects will be randomized to receive a single dose of OxyNorm® 2.5, 5, and 10mg | Drug: Oxycodone (OxyNorm®) Injection<br>* The subjects will be randomized to receive a single dose of OxyNorm® 2.5, 5, and 10mg.The plasma concentration will be analyzed to determine the following pharmacokinetic parameters:AUC0-t:ug•hr/L-Area under the plasma concentration-time curve frame: predose,0,2min,5min,10min,15min,30min,45min,1hr,1.5hr,2hr,3hr,4hr,6hr,8hr,12hr, 24hr post-dose.AUC0-inf:ug•hr/L-Area under the plasma concentration-time curve extrapolated to infinity. Cmax: ug/L-Maximum observed plasma concentration of oxycodone and noroxycodone.Tmax: hrs-time at which Cmax is first observed. t½: Apparent half life of oxycodone elimination.<br>* Other names: OxyNorm®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) concentrations of oxycodone hydrochloride injection at various time points: predose, 0min, 2min, 5min, 10min, 15min, 30min, 45min, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24hr post dose. | Plasma concentrations of oxycodone and Noroxycodone and Oxymorphone will be analyzed. | 2 days |