OxyNorm® Capsules (Immediate-Release) Pharmacokinetic (PK) Study
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|ClinicalTrials.gov Identifier: NCT01643772|
Recruitment Status : Completed
First Posted : July 18, 2012
Last Update Posted : August 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: OxyNorm® Capsules (Oxycodone Hydrochloride)||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||OxyNorm® Capsules (Immediate-Release) PK Study|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
|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
- Area under curve (AUC) [ Time Frame: predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose. ]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 ]To investigate the pharmacokinetic profile, dose-proportionality, and evaluate drug accumulation of Oxycodone Hydrochloride after multiple dose of OxyNorm® capsules.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643772
|Affiliated Hospital to Academy of Military Medical Science of China People's Liberation Army|
|Study Chair:||Mundipharma China Ltd.||Mundipharma China Ltd.|