Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-02-06 @ 1:23 PM
Study NCT ID:
NCT03145259
Status:
COMPLETED
Last Update Posted:
2020-06-30
First Post:
2017-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Bioavailability of Diclofenac Dermal Products
Sponsor:
University of Maryland, Baltimore
Organization:
Study Overview
Official Title:
Evaluation of Bioavailability of Diclofenac Dermal Products
Status:
COMPLETED
Status Verified Date:
2020-06
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 study will utilize already FDA-approved marketed diclofenac products in healthy adults to generate data for establishing rate of drug delivery comparisons between diclofenac epolamine patches and diclofenac sodium solution in healthy adults and to determine skin concentrations.
Detailed Description:
The study will utilize already FDA-approved marketed diclofenac products in healthy adults to generate data for establishing rate of drug delivery comparisons between diclofenac epolamine patches and diclofenac sodium solution in healthy adults and to determine skin concentrations. This study supports FDA's continuing effort to identify the most accurate, sensitive, reproducible and efficient methods to evaluate topical dermatological drug products.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: