Pain
Conditions
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.
Interventions
DRUGOxycodone (OxyNorm®) Injection
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.
Sponsors
Mundipharma (China) Pharmaceutical Co. Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 2 days | Plasma concentrations of oxycodone and Noroxycodone and Oxymorphone will be analyzed. |
Countries
China
Outcome results
None listed