Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-03 @ 2:22 AM
Study NCT ID:
NCT01643759
Status:
COMPLETED
Last Update Posted:
2015-07-08
First Post:
2011-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Norspan Transdermal Patches Study in Osteoarthritis Patients
Sponsor:
Mundipharma (China) Pharmaceutical Co. Ltd
Organization:
Study Overview
Official Title:
A Single Dose PK Study of BTDS 5, 10, and 20 in Chinese Osteoarthritis Patients
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single center, open label, randomized, parallel group single dose pharmacokinetic (PK) study.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: