At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 34 enrolled
Drug / intervention
Diclofenac sodium gel +1 moredrug
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, Multiple-dose, Single-center, Randomized, Open-label, 2-period, 2-treatment Crossover Systemic Bioavailability Study of Diclofenac Comparing AMZ001 (Diclofenac Sodium Gel) Applied Once Daily on Each Knee Diclofenac Diethylammonium Gel 1.16% Applied 4 Times Daily on Each Knee in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Diclofenac sodium gel and Diclofenac diethylamine 1.16% gel for Healthy Volunteer. Completed, enrolled 34 participants across 1 site.
Detailed Summary
The aim of the present study is to investigate the systemic bioavailability of AMZ001, applied once daily on each knee compared to Diclofenac diethylammonium gel 1.16%, applied 4 times daily on each knee, after repeated dosing in healthy subjects for 7 days The safety and local tolerability of AMZ001, applied once daily, will be evaluated after repeated dosing in healthy subjects for 7 days
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteer
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20252026
Enrollment StartNov 2024
First PostedDec 2024
Primary CompletionJun 2025
Study CompletionJul 2025
TodayJul 2026
First PostedDec 11, 2024
Enrollment StartNov 29, 2024
Primary CompletionJun 10, 2025
Study CompletionJul 15, 2025
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 1.6 years ago
Interventions
Diclofenac sodium geldrug
topical administration
Diclofenac diethylamine 1.16% geldrug
Topical administration