OxyNorm® Capsules (Immediate-Release) Pharmacokinetic (PK) Study
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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||OxyNorm® Capsules (Immediate-Release) PK Study|
- Area under curve (AUC) [ Time Frame: predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose. ] [ Designated as safety issue: Yes ]To investigate the pharmacokinetic profile, dose-proportionality, and evaluate drug accumulation of Oxycodone Hydrochloride after single dose of OxyNorm® capsules.
- Area Under Curve (AUC) of time frame for multi-dose: Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day. [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]To investigate the pharmacokinetic profile, dose-proportionality, and evaluate drug accumulation of Oxycodone Hydrochloride after multiple dose of OxyNorm® capsules.
|Study Start Date:||May 2011|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
|Experimental: OxyNorm® Capsules||
Drug: OxyNorm® Capsules (Oxycodone Hydrochloride)
The subjects will be randomized to receive either a single dose of OxyNorm® Capsules 5, 10, 20mg, or multiple-dose OxyNorm® Capsules 10 mg for 13 times.
Other Name: No other name
Single dose: The subjects will be randomized to receive a single dose of OxyNorm® immediate-release capsules 5, 10, and 20mg.
Multiple dose: The subjects will take 3 days OxyNorm® capsule 10mg, once every 6 hours, 10mg per dose. In the morning of the 4th day, the subjects will take single dose of OxyNorm® capsule 10mg. On the 5th day, all the subjects complete the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643772
|Affiliated Hospital to Academy of Military Medical Science of China People's Liberation Army|
|Study Chair:||Mundipharma China Ltd.||Mundipharma China Ltd.|