drugset / Trial / NCT05968482
Bioavailability and Safety Study Comparing Two Dose Levels of AMZ001 and One Dose Level of Diclofenac Sodium 1% Gel in Healthy Participants
RandomizedCrossoverOpen-labelTreatment
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.
Timeline
- Start
- 2023-07-11
- Primary completion
- 2023-12-27
- Completion
- 2024-12-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Diclofenac | Other / unclassified | 1 % | Topical |
| Subject | Diclofenac | Other / unclassified | 3.06 % | Topical |
Indications
No indication recorded.