Norspan Transdermal Patches Study in Osteoarthritis Patients
This is a single center, open label, randomized, parallel group single dose pharmacokinetic (PK) study.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single Dose PK Study of BTDS 5, 10, and 20 in Chinese Osteoarthritis Patients|
- Area Under Curve (AUC) [ Time Frame: Pre-dose, 6hr, 12hr, 24hr, 36hr, 48hr, 60hr, 72hr, 96hr, 120hr, 144hr,168hr, 169hr, 170hr, 171hr, 172hr, 174hr, 180hr, 192hr, 216hr, 240hr post dose. ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2009|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Experimental: buprenorphine transdermal system
buprenorphine transdermal system
The subjects will be randomized to receive either a single dose of BTDS 5, or BTDS 10, or BTDS 20 for 7 days. Plasma concentrations of buprenorphine and norbuprenorphine will be analyzed to determine the following pharmacokinetic parameters: AUC0-t:pg•hr/ml-Area under the plasma concentration-time curve frame: predose,6,12,24,36,48,60,72,96,120,144,168,169,170,171,172,174,180,192,216,240 hours post-dose.AUC0-inf:pg•hr/ml-Area under the plasma concentration-time curve extrapolated to infinity. Cmax: pg/ml-Maximum observed plasma buprenorphine concentration. Tmax: hrs-time at which Cmax is first observed. t½: Apparent half life of buprenorphine elimination.
Other Name: Norspan
After up to 7-day screening period, Eligible Patients will be randomized to 1 of 3 treatment groups, and begin treatment with BTDS 5mg, 10mg,20mg for 7 days.Venous blood will be collected at 0, 6, 12, 24, 36, 48, 60, 72, 96,120, 144,168,169,170,171,172,174,180,192,216, 240 h postdose respectively.Plasma concentrations of buprenorphine and norbuprenorphine will be analyzed to determine the following pharmacokinetic parameters: AUC0-t, AUC0-inf, Cmax, Tmax, t½.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643759
|Investigational Site: Peking Union Medical Hospital(PUMC)|
|Study Chair:||Mundipharma China Ltd.||Mundipharma China Ltd.|