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

NCT05968482 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-04-09

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

Diclofenac Sodium Gel

Topical application on both knees

Sponsors & Collaborators

  • Amzell

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-11
Primary Completion
2023-12-27
Completion
2024-12-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05968482 on ClinicalTrials.gov