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First received: July 07, 2023

Clinical Trial: Bioavailability and Safety Study Comparing Two Dose Levels of AMZ001 and One Dose Level of Diclofenac Sodium 1% Gel in Healthy Participants

Study Status: Completed

Recruit Status: RECRUITING

Condition: Healthy

Study Type: INTERVENTIONAL


Official Title: A Phase 1, Single-Center, Randomized, Open-Label, Bioavailability and Safety Three Period Crossover Multiple-Dose Study Comparing Two Dose Levels of AMZ001 (Diclofenac Sodium Gel 3.06%) and One Dose L

Brief Summary: The goal of this clinical trial is to compare drug exposure from two different products (AMZ001 and Diclofenac Sodium 1% Gel) in healthy participants on Day 7 after repeated topical administrations for 7 days.Participants will receive, in a crossover design, three different treatmentsAMZ001 Low doseAMZ001 High doseDiclofenac Sodium 1% GelSafety and tolerability of AMZ001 will be also investigated.

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