Healthy VolunteerPhase 1AMZ001NCT06729073
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 study testing Diclofenac sodium gel and Diclofenac diethylamine 1.16% gel in people with Healthy Volunteer, run by Amzell at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Diclofenac sodium gel and Diclofenac diethylamine 1.16% gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- 29 Nov 2024to 15 Jul 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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.
- Use of any investigational drug or participation in any clinical study within 30 days or 10 half-life times (if known) of study drug administered in a previous trial, whichever is longer, prior to the expected date of first administration of study intervention.
- Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV) and anti-human immunodeficiency virus antibodies (anti-HIV 1 and 2 and HIV 1-p24 antigen) at screening
- Positive screen for alcohol, drugs of abuse and cotinine test at screening.
- Female subject who plans to become pregnant during the clinical study period and for 3 months after final study intervention administration
- Donation or blood collection of more than 1 unit (approximately 450 mL) of blood (or blood products) or acute loss of blood during the 30 days prior to randomization.
- Employee of the Sponsor, or Contract Research Organization (CRO) involved in the clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
Read the 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
- Being tested
- Diclofenac sodium gel, Diclofenac diethylamine 1.16% gel
- Keywords
- pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac sodium gelDrug
topical administration
Diclofenac diethylamine 1.16% gelDrug
Topical administration
| Study group | Role | What they receive |
|---|---|---|
| AMZ001 | Experimental | AMZ001 applied once daily for 7 consecutive days Receives: Drug: Diclofenac sodium gel |
| Diclofenac diethylamine 1.16% | Active comparator | Reference product applied four-times daily for 7 consecutive days Receives: Drug: Diclofenac diethylamine 1.16% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve 0-24h
Area under the curve from time zero to 24 hours
Measured: Day 7
Secondary outcomes (7)
Pharmacokinetic Parameter - Cmin
Minimum plasma drug concentration (Cmin)
Measured: Day 7
Pharmacokinetic Parameter - Cavg
Average plasma concentration (Cavg)
Measured: Day 7
Pharmacokinetic Parameter - Tmax
Time to reach maximum plasma concentration (Tmax)
Measured: Day 7
Compare Exposure to Diclofenac
Area under the curve from time zero to 24 hours and maximum (peak) plasma drug concentration
Measured: Day 1
Pharmacokinetic Parameter - Tmax
Time to reach maximum plasma concentration (Tmax)
Measured: Day 1
Pharmacokinetic Parameter - Cavg
Average plasma concentration
Measured: Day 1
Incidence of Application Site Reactions
Number of subjects having at least one event
Measured: Day 1 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start29 Nov 2024
- Primary completion10 Jun 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amzell
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729073
- Sponsor's protocol ID
- AMZ001-009
- Acronym
- AMZ001
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2024
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06729073
- Acronym / sponsor ID
- AMZ001 / AMZ001-009
- Conditions
- Healthy Volunteer
- Keywords
- pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- AmzellIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 11 Dec 2024 (actual)
- Results
- Posted 6 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMZ001 | Experimental | Drug: Diclofenac sodium gelAMZ001 applied once daily for 7 consecutive days |
| Diclofenac diethylamine 1.16% | Active comparator | Drug: Diclofenac diethylamine 1.16% gelReference product applied four-times daily for 7 consecutive days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diclofenac sodium geltopical administration | Drug | AMZ001 |
| Diclofenac diethylamine 1.16% gelTopical administration | Drug | Diclofenac diethylamine 1.16% |
Primary outcome
Area Under the Curve 0-24h
Time frame: Day 7
Area under the curve from time zero to 24 hours
7 secondary outcomes
Pharmacokinetic Parameter - Cmin
Time frame: Day 7
Pharmacokinetic Parameter - Cavg
Time frame: Day 7
Pharmacokinetic Parameter - Tmax
Time frame: Day 7
Compare Exposure to Diclofenac
Time frame: Day 1
Pharmacokinetic Parameter - Tmax
Time frame: Day 1
Pharmacokinetic Parameter - Cavg
Time frame: Day 1
Incidence of Application Site Reactions
Time frame: Day 1 to Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Diclofenac sodium gel and Diclofenac diethylamine 1.16% gel in people with Healthy Volunteer, run by Amzell at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve 0-24h (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.