At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 74 enrolled
Drug / intervention
Diclofenac Sodium Geldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 Level of Diclofenac Sodium 1% Gel in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Diclofenac Sodium Gel for Healthy. Completed, enrolled 74 participants across 1 site.
Detailed 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 treatments * AMZ001 Low dose * AMZ001 High dose * Diclofenac Sodium 1% Gel Safety and tolerability of AMZ001 will be also investigated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
202420252026
Enrollment StartJul 2023
First PostedAug 2023
Primary CompletionDec 2023
Study CompletionDec 2024
TodayJul 2026
First PostedAug 1, 2023
Enrollment StartJul 11, 2023
Primary CompletionDec 27, 2023
Study CompletionDec 2, 2024
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 2.9 years ago
Interventions
Diclofenac Sodium Geldrug
Topical application on both knees