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.

NCT06729073 | Completed Phase 1 Results FDA Drug

• 1 other identifier: AMZ001-009
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Volunteer

Keywords

pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve 0-24h

  Area under the curve from time zero to 24 hours

  Day 7

Secondary Outcomes (7)

• Pharmacokinetic Parameter - Cmin

  Day 7

• Pharmacokinetic Parameter - Cavg

  Day 7

• Pharmacokinetic Parameter - Tmax

  Day 7

• Compare Exposure to Diclofenac

  Day 1

• Pharmacokinetic Parameter - Tmax

  Day 1

Study Arms (2)

AMZ001

EXPERIMENTAL

AMZ001 applied once daily for 7 consecutive days

Drug: Diclofenac sodium gel

Diclofenac diethylamine 1.16%

ACTIVE COMPARATOR

Reference product applied four-times daily for 7 consecutive days

Drug: Diclofenac diethylamine 1.16% gel

Interventions

Diclofenac sodium gel DRUG

topical administration

AMZ001

Diclofenac diethylamine 1.16% gel DRUG

Topical administration

Diclofenac diethylamine 1.16%

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) within the range of 18.0-30.0 kg/m\^2 (inclusive) at screening
• Female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
• Is a WONCBP. A WOCBP must have a negative highly sensitive serum pregnancy test at screening OR
• Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency, without interruption, during trial participation and until 30 days after the last administration of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period.
• Participant is overtly healthy as determined by medical evaluation including medical history, full physical examination, vital signs, and ECG
• Participant is free of any systemic or dermatologic disorder and chronic or acute infections, which, in the opinion of the Investigator, may interfere with the study results or increase the risk of adverse events.
• Participant is a non-smoker, former smoker or stable non-smoker (= 0 cigarettes, pipes, cigars, or others) for at least 3 months prior to screening. Participant must also have abstained from use of other nicotine containing products (e.g., nicotine patch, chewing gum or e-cigarettes) for at least 3 months before screening.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol prior to any clinical study specific procedure.

You may not qualify if:

• Any visible skin disease, skin lesions, wounds, or a significant amount of hair at the application sites (both knees).
• Any history or evidence of any clinically relevant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinologic, hematologic, immunologic, metabolic, genitourinary, pulmonary, neurologic, dermatologic, musculoskeletal, psychiatric and/or other major disease as determined by medical evaluation (including \[abbreviated\] physical examination) capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
• Any known or suspected malignancy, excluding basal cell cancer unless it is associated with the treatment area.
• Any gastrointestinal bleeding issues, e.g., Gastroesophageal Reflux Disease, Peptic Ulcer Disease.
• Any hospital admission or major surgery within 30 days prior to randomization
• History or current evidence of ongoing hepatic disease or impaired hepatic function at screening as indicated by diagnostic assessments
• History or current evidence of renal disease or impaired renal function at screening as indicated by diagnostic assessments
• Any clinically relevant history of allergic conditions requiring hospitalization or prolonged systemic treatment (including drug allergies, drug hypersensitivity, asthma, angioedema, urticaria, eczema, acute rhinitis precipitated by acetylsalicylic acid or other NSAIDs, allergies requiring therapy with corticosteroids or anaphylactic reactions), excluding allergic contact sensitizations (e.g., nickel allergy). Subjects with uncomplicated seasonal allergic rhinitis can be accepted only if the expected allergy season is clearly outside enrolment/ treatment periods.
• Known or suspected hypersensitivity to diclofenac, or any components of the formulations used
• Contraindications for the use of study interventions
• Any clinically relevant chronic or acute infectious illnesses or febrile infections within 2 weeks prior to the first scheduled administration of study intervention
• Evidence of COVID-19 signs or symptoms or confirmed COVID-19 infection within the last 2 weeks prior to screening.
• Treatment with systemic or local diclofenac within 30 days of enrollment or during the study (except for study interventions).
• Use of any concomitant medication or any drugs / medicines (including over-the-counter medication, dietary supplements, natural and herbal remedies) within 2 weeks before the first scheduled administration of study intervention or within less than 10 times the elimination half-life of the respective drug (whichever is longer) or is anticipated to require concomitant medication during the 2-week period or at any time throughout the study.
• Use of any topical medication, cosmetics, cream, ointments, lotions on the treatment site 2 weeks prior to enrollment through EOT visit.

Sponsors & Collaborators

• Amzell: lead

Study Sites (1)

Nuvisan

Neu-Ulm, Germany

Location

MeSH Terms

Interventions

diclofenac diethylamine; Gels

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Delpy
• Organization: AMZELL BV

amzell-disclosure@amzell.com

+31235560460

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 11, 2024
• Study Start: November 29, 2024
• Primary Completion: June 10, 2025
• Study Completion: July 15, 2025
• Last Updated: January 6, 2026
• Results First Posted: January 6, 2026

Record last verified: 2025-12

Locations

DE (1)