drugset / Trial / NCT06729073
Comparison of Diclofenac Systemic Exposure From Two Different Products (AMZ001 and Diclofenac Diethylammonium 1.16% Gel) in Healthy Participants After Repeated Topical Administrations for 7 Days.
RandomizedCrossoverOpen-labelTreatment
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
Timeline
- Start
- 2024-11-29
- Primary completion
- 2025-06-10
- Completion
- 2025-07-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Diclofenac | Other / unclassified | 1.16 % | Topical |
| Comparator | Diclofenac | Other / unclassified | — | Topical |
Indications
No indication recorded.