Pharmacokinetic (PK) Study of OxyNorm Injections in Chinese Patient
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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Area under the plasma concentration(AUC)of drug oxycodone hydrochloride injection at the time frames:predose,0min,2min,5min,10min,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post dose. [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]Plasma concentrations of oxycodone and , Noroxycodone and Oxymorphone will be analyzed to determine it.
|Study Start Date:||May 2010|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
|Experimental: OxyNorm® Injections||
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482936
|Investigational Site: Affiliated Hospital to Academy of Military Medical Science of China People's Liberation Army|
|Study Chair:||Mundipharma China Ltd.||Mundipharma China Ltd.|