Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00388219
Status:
TERMINATED
Last Update Posted:
2007-07-06
First Post:
2006-10-13
Brief Title:
Single Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations
Sponsor:
Grünenthal GmbH
Organization:
Grünenthal GmbH
Study Overview
Official Title:
Single Dose Bioequivalence Trial Comparing a New Analgesic Transdermal Patch Formulation to an Analgesic Reference Patch
Status:
TERMINATED
Status Verified Date:
2007-07
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:
The purpose of this study is to determine whether Transtec R PRO 70 µgh and a new buprenorphine patch formulation lead to same plasma levels of buprenorphine after single dose application
Detailed Description:
Main to demonstrate the bioequivalence of the new buprenorphine transdermal patch T2rev formulation containing 13 mg buprenorphine Test as compared to Transtec R PRO 70 µgh patch transdermal patch containing 40 mg buprenorphine as reference Reference after single patch application Pharmacokinetic target parameters are AUC AUCo-t and Cmax
Further To assess the safety tolerability skin tolerability and adhesiveness of the patch applications
Further To assess the safety tolerability skin tolerability and adhesiveness of the patch applications
Study Oversight
Has Oversight DMC:
None
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?:
None