Completed EARLY_PHASE1 INTERVENTIONAL 4-arm NCT01592019

Clinical Study to Evaluate the Role of Microdialysis for the Comparison of Topical Products

Use of Dermal Microdialysis to Evaluate the Effect of Skin Properties and Application Site on the Topical Bioequivalence of Diclofenac: The Main Study

Sponsor: Food and Drug Administration (FDA)

Conditions Bioequivalence

Interventions Reference, Patch location abdomen, batch 1 Reference, Patch location thigh, batch 1 Test, Patch location abdomen, batch 2 Test, Patch location thigh, batch 2

Updated 6 times since 2017 Last updated: Dec 12, 2012 Started: Apr 30, 2012 Primary completion: Nov 30, 2012 Completion: Nov 30, 2012

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This EARLY_PHASE1 trial investigates Bioequivalence and is currently completed. Food and Drug Administration (FDA) leads this study, which shows 6 recorded versions since 2012 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed EARLY_PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed EARLY_PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed EARLY_PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed EARLY_PHASE1
Feb 2017 — Jun 2018 [monthly]

Completed EARLY_PHASE1

Phase: Phase 0 → EARLY_PHASE1

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Completed Phase 0

First recorded

Apr 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Food and Drug Administration (FDA)
University of Florida

Data source: University of Florida

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Gainesville, United States