Ignite Creation Date:
2024-05-06 @ 7:11 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02486016
Status:
COMPLETED
Last Update Posted:
2020-03-23
First Post:
2015-06-26
Brief Title:
Transdermal Patch CVD 2000 The Effect of Heat on Fentanyl Release From Fentanyl TDSs in Healthy Adults
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Determination of Serum Fentanyl Levels After Using Reference and Generic Transdermal Fentanyl TDSs With and Without Standardized Heat Application in Healthy Human Volunteers
Status:
COMPLETED
Status Verified Date:
2020-03
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 an Open-label Non-Randomized 3-way Crossover Bioequivalence Study to compare fentanyl release after heating of a brand name Duragesic and generic Apotex and Mylan fentanyl transdermal delivery systemTDSs in healthy adults
Detailed Description:
This research study is intended to determine the effect of heat on FDA-approved fentanyl TDSs and whether the heat applied will result in more fentanyl being absorbed through the skin than without applying heat This is important given that little is known about how the release of fentanyl is affected by heat particularly for generic products This study will use fentanyl TDSs brand name and generic TDSs that have been approved by the Food and Drug Administration FDA and are already prescribed to customers in the United States and will not include any placebos
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