Trials / Completed
CompletedNCT03145259
Evaluation of Bioavailability of Diclofenac Dermal Products
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- University of Maryland, Baltimore · Academic / Other
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Diclofenac Epolamine Patch | patch |
| DRUG | diclofenac sodium solution | solution |
Timeline
- Start date
- 2017-04-19
- Primary completion
- 2019-08-29
- Completion
- 2020-05-15
- First posted
- 2017-05-09
- Last updated
- 2020-06-30
- Results posted
- 2020-06-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03145259. Inclusion in this directory is not an endorsement.