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Evaluation of Bioavailability of Diclofenac Dermal Products

NCT03145259 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-06-30

Study results available
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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.

Conditions

  • Bioavailability

Interventions

DRUG

Diclofenac Epolamine Patch

patch

DRUG

diclofenac sodium solution

solution

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Audra L Stinchcomb, PhD · University of Maryland Baltimore School of Pharmacy

  • Hazem E Hassan, PhD · University of Maryland Baltimore School of Pharmacy

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-19
Primary Completion
2019-08-29
Completion
2020-05-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03145259 on ClinicalTrials.gov