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.

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Amzell · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed description

On their both knees, participants will apply once daily AMZ001 for 7 consecutive days. Participants will also apply Diclofenac Diethylammonium 1.16% Gel as per label information on each knee. Intensive pharmacokinetic assessment (blood samplings) will be performed on the first day of application (Day 1) as well as on the last day of application (Day 7). Each participant will receive each of the two treatments in a randomized manner. Between each treatment, participant will not receive any of tested therapies during at least 21 days before receiving the next therapy. (washout period) Participants will stay on the clinical unit only during each period of treatment but not during washout period.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Diclofenac sodium gel	topical administration
DRUG	Diclofenac diethylamine 1.16% gel	Topical administration

Timeline

• Start date: 2024-11-29
• Primary completion: 2025-06-10
• Completion: 2025-07-15
• First posted: 2024-12-11
• Last updated: 2026-01-06
• Results posted: 2026-01-06

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study