HealthyPhase 1NCT05968482

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

A Phase 1 study testing Diclofenac Sodium Gel in people with Healthy, run by Amzell at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Diclofenac Sodium Gel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 1 siteUnited States
Study dates: 11 Jul 2023to 2 Dec 2024
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

Healthy male or female participants 18-65 years of age (e.g., in general good physical health, as judged by the Investigator and no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG (electrocardiogram) or clinical laboratory tests)
Has a body mass index (BMI) between 18.0 and 35.0 kg/m^2 (kilogram per square meter) at Screening.
In the case of females of child-bearing potential ([FCBP) unless surgically sterilized [hysterectomy, bilateral oophorectomy, bilateral tubal ligation] or are postmenopausal for at least 12 months), are using two acceptable forms of birth control (hormonal contraceptives i.e., oral/implant/injectable/transdermal; intrauterine device (IUD) and/or barrier methods [female condom, male condom, diaphragm, cervical cap, spermicide]; note: 2 barrier methods are two acceptable forms of birth control)). Abstinence or partner's vasectomies are acceptable if the female participant agrees to implement two acceptable forms of birth control if her lifestyle/partner changes.
Females of child-bearing potential have a negative serum pregnancy test (SPT) at Screening and negative urine pregnancy test (UPT) on Day -1 of each period and at end of treatment (EOT) visit
Are free of any systemic or dermatologic disorder and chronic or acute infections, which, in the opinion of the Principal Investigator (PI), will interfere with the study results or increase the risk of adverse events (AEs)
Read, understand, and provide signed informed consent before any assessment is performed.

Who cannot join

Participant has any visible skin disease, skin lesions, wounds, or a significant amount of hair at the application site (knee)
Use of an investigational medicinal product (IMP) within 30 days or 5 half-lives (if known), whichever is longer, of enrollment or during the study.
Treated with systemic or local diclofenac within 30 days of enrollment or during the study (except for study IMP)
Known hypersensitivity to diclofenac, aspirin, Xarelto, coumadin, or other non-steroidal anti-inflammatory drugs (NSAIDs), including Cyclooxygenase-2 (COX-2) inhibitors.
Any history of drug hypersensitivity, asthma, urticaria, or other significant allergic diathesis. Participants with uncomplicated seasonal allergic rhinitis can be accepted only if the expected allergy season is clearly outside enrollment / treatment periods.
Females who are pregnant and/or lactating

Show all 22Show fewer

Of child-bearing potential but not willing to use adequate contraception for the duration of the study
Participant is a current smoker and unable to abstain from smoking during the treatment periods.
Use of any topical medication, cosmetics, cream, ointments, lotions on the treatment site 1 week prior to enrollment through EOT visit
Use of any medication (including over-the-counter medication, dietary supplements, and herbal remedies) within 2 weeks before first scheduled study drug administration or within less than 5 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. Consumption of any drug metabolizing enzyme (e.g., cytochrome P450 3A4 (CYP3A4) or other cytochrome P450 enzymes) inducing or inhibiting beverages or food (e.g., broccoli, Brussel sprouts, grapefruit, grapefruit juice, star fruit) within 3 days prior to and during each treatment period
Participant has a known or suspected malignancy, excluding basal cell cancer unless it is associated with the treatment area.
Participant has a positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C antibody (Anti-HCV)
Participant has any acute or chronic condition or is using medications, which, in the investigator's opinion, would make it unsafe for the participant to participate in this study, including clinically significant abnormal laboratory values, vital signs, physical examination findings prior to randomization or during study participation.
History or current evidence of renal disease or impaired renal function at screening as indicated by abnormal levels of serum creatinine (greater than (>) 1.43 mg/dL (milligram per deciliter)) or blood urea nitrogen (greater than or equal to (≥) 35 mg/dL) or the presence of clinical significant abnormal urinary constituents (e.g., albuminuria)
History or current evidence of ongoing hepatic disease or impaired hepatic function at screening. A participant will be excluded if more than one of the following lab value deviations are found: 1) aspartate aminotransferase (AST) (≥ 1.5 upper limit of normal (ULN)), alanine aminotransferase (ALT) (≥ 1.5 ULN), 2) Gamma-Glutamyl Transferase (GGT) (≥ 1.5 ULN), alkaline phosphatase (ALP) (≥ 1.5 ULN), 3) total bilirubin (> 2.00 mg/dL) or creatine kinase (≥ 3 ULN). A single deviation from the above values is acceptable and will not exclude the participant, unless specifically advised by the Investigator.
Participant has clinically relevant chronic or acute infectious illnesses or febrile infections within 2 weeks prior to the first scheduled study drug administration
Participant has gastrointestinal bleeding issues, e.g., Gastroesophageal Reflux Disease (GERD), Peptic Ulcer Disease (PUD)
Participant has a hospital admission or major surgery within 30 days prior to randomization.
Participant has a donation or blood collection of more than 1 unit (approximately 450 mL(milliliter)) of blood (or blood products) or acute loss of blood during the 30 days prior to randomization.
Participant has a history of alcohol abuse, prescription drug abuse, or illicit drug use within 6 months prior to Screening.
Participant meets eligibility criteria, but study is filled
Participant who is an investigational site staff member directly involved in the conduct of the study and his/her family members, site staff member otherwise supervised by the Investigator, or participant who is a Amzell B.V. employee directly involved in the conduct of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

TKL Research
Fair Lawn, New Jersey, 07410

Other trials in United States

About this study

Official title: A Phase 1, Single-Center, Randomized, Open-Label, Bioavailability and Safety Three Period Crossover Multiple-Dose Study Comparing Two Dose Levels of AMZ001 (Diclofenac Sodium Gel 3.06%) and One Dose Level of Diclofenac Sodium 1% Gel in Healthy Subjects

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.

Read the detailed description

On their both knees, participants will apply once daily either low dose of AMZ001 or high dose of AMZ001 for 7 consecutive days. Participants will also apply Diclofenac Sodium 1% 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 three treatments in a randomized manner. Between each treatment, participant will not receive any of the three tested therapies between 3 weeks 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
Being tested: Diclofenac Sodium Gel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diclofenac Sodium GelDrug
Topical application on both knees

Study groups in NCT05968482
Study group	Role	What they receive
AMZ001 Low dose	Experimental	AMZ001 applied once daily for 7 consecutive days Receives: Drug: Diclofenac Sodium Gel
AMZ001 High dose	Experimental	AMZ001 applied once daily for 7 consecutive days Receives: Drug: Diclofenac Sodium Gel
Diclofenac Sodium 1% Gel	Active comparator	Reference product applied four-times daily for 7 consecutive days Receives: Drug: Diclofenac Sodium Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

Compare Exposure to Diclofenac
Area under the curve (AUC) from time zero to 24 hours
Measured: Day 7
Pharmacokinetic Parameter - Cmax
Maximum plasma drug concentration (Cmax)
Measured: Day 1

Secondary outcomes (7)

Pharmacokinetic Parameter - Cmin
Minimum plasma drug concentration (Cmin)
Measured: Day 7
Pharmacokinetic Parameter - Tmax
Time to reach maximum plasma concentration (Tmax)
Measured: Day 7
Pharmacokinetic Parameter - Ke
Terminal disposition rate constant (Ke)
Measured: Day 7
Pharmacokinetic Parameter - Cavg
Average plasma concentration (Cavg)
Measured: Day 7
Pharmacokinetic Parameter - Tmax
Time to reach maximum plasma concentration
Measured: Day 1
Pharmacokinetic Parameter - Cavg
Average plasma concentration (Cavg)
Measured: Day 1
Local Tolerability
Incidence of application site reactions according to the terminology of the International Contact Dermatitis Research Group
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.

11 Jul 20232 Dec 2024

First posted1 Aug 2023
Study start11 Jul 2023
Primary completion27 Dec 2023
Study completion2 Dec 2024

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 HealthyStudies 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: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05968482
Sponsor's protocol ID: AMZ001-008
Status last verified: Mar 2025
First submitted: 7 Jul 2023
Last updated: 9 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Single-Center, Randomized, Open-Label, Bioavailability and Safety Three Period Crossover Multiple-Dose Study Comparing Two Dose Levels of AMZ001 (Diclofenac Sodium Gel 3.06%) and One Dose Level of Diclofenac Sodium 1% Gel in Healthy Subjects
ClinicalTrials.gov ID: NCT05968482
Acronym / sponsor ID: AMZ001-008
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: AmzellIndustry (pharma, biotech, devices)
Study start: 11 Jul 2023 (actual)
Primary completion: 27 Dec 2023 (actual)
Study completion: 2 Dec 2024 (actual)
First posted: 1 Aug 2023 (actual)
Results: Posted 9 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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).

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: 3

Arm	Type	Receives
AMZ001 Low dose	Experimental	Drug: Diclofenac Sodium GelAMZ001 applied once daily for 7 consecutive days
AMZ001 High dose	Experimental	Drug: Diclofenac Sodium GelAMZ001 applied once daily for 7 consecutive days
Diclofenac Sodium 1% Gel	Active comparator	Drug: Diclofenac Sodium 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 (6 listed)

Healthy male or female participants 18-65 years of age (e.g., in general good physical health, as judged by the Investigator and no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG (electrocardiogram) or clinical laboratory tests)
Has a body mass index (BMI) between 18.0 and 35.0 kg/m^2 (kilogram per square meter) at Screening.
In the case of females of child-bearing potential ([FCBP) unless surgically sterilized [hysterectomy, bilateral oophorectomy, bilateral tubal ligation] or are postmenopausal for at least 12 months), are using two acceptable forms of birth control (hormonal contraceptives i.e., oral/implant/injectable/transdermal; intrauterine device (IUD) and/or barrier methods [female condom, male condom, diaphragm, cervical cap, spermicide]; note: 2 barrier methods are two acceptable forms of birth control)). Abstinence or partner's vasectomies are acceptable if the female participant agrees to implement two acceptable forms of birth control if her lifestyle/partner changes.
Females of child-bearing potential have a negative serum pregnancy test (SPT) at Screening and negative urine pregnancy test (UPT) on Day -1 of each period and at end of treatment (EOT) visit
Are free of any systemic or dermatologic disorder and chronic or acute infections, which, in the opinion of the Principal Investigator (PI), will interfere with the study results or increase the risk of adverse events (AEs)

Key exclusion criteria (22 listed)

Participant has any visible skin disease, skin lesions, wounds, or a significant amount of hair at the application site (knee)
Use of an investigational medicinal product (IMP) within 30 days or 5 half-lives (if known), whichever is longer, of enrollment or during the study.
Treated with systemic or local diclofenac within 30 days of enrollment or during the study (except for study IMP)
Known hypersensitivity to diclofenac, aspirin, Xarelto, coumadin, or other non-steroidal anti-inflammatory drugs (NSAIDs), including Cyclooxygenase-2 (COX-2) inhibitors.
Any history of drug hypersensitivity, asthma, urticaria, or other significant allergic diathesis. Participants with uncomplicated seasonal allergic rhinitis can be accepted only if the expected allergy season is clearly outside enrollment / treatment periods.

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 application on both knees	Drug	AMZ001 High dose, AMZ001 Low dose, Diclofenac Sodium 1% Gel

Primary outcome

Compare Exposure to Diclofenac
Time frame: Day 7
Area under the curve (AUC) from time zero to 24 hours
Pharmacokinetic Parameter - Cmax
Time frame: Day 1
Maximum plasma drug concentration (Cmax)

7 secondary outcomes

Pharmacokinetic Parameter - Cmin
Time frame: Day 7
Pharmacokinetic Parameter - Tmax
Time frame: Day 7
Pharmacokinetic Parameter - Ke
Time frame: Day 7
Pharmacokinetic Parameter - Cavg
Time frame: Day 7
Pharmacokinetic Parameter - Tmax
Time frame: Day 1
Pharmacokinetic Parameter - Cavg
Time frame: Day 1
Local Tolerability
Time frame: Day 1 to Day 7

Results and safety

Results posted to the registry on 9 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AMZ001 Low / AMZ001 High / Diclofenac	12	12
Diclofenac/AMZ001 High/AMZ001 Low	12	12
Diclofenac/AMZ001 Low/AMZ001 High	12	11
AMZ001 High/AMZ001 Low/Diclofenac	13	13
AMZ001 Low/Diclofenac/AMZ001 High	13	13
AMZ001 High/Diclofenac/AMZ001 Low	12	11

Primary outcome: Compare Exposure to Diclofenac

Time frame: Day 7. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	AMZ001 Low Dose n = 69	AMZ001 High Dose n = 69	Diclofenac Sodium 1% Gel n = 69
Value	141.5 (89.8)	166.1 (90.3)	202.3 (79.4)

Population analysed: All subjects for which at least AUC0-τ or Cmax can be determined for the reference treatment (Diclofenac Sodium 1% Gel) along with at least one of Treatments AMZ001 Low dose or AMZ001 High dose are included in the analysis population.

Primary outcome: Pharmacokinetic Parameter - Cmax

Time frame: Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	AMZ001 Low Dose n = 69	AMZ001 High Dose n = 69	Diclofenac Sodium 1% Gel n = 69
Value	4.66 (122.4)	6.22 (128.9)	3.85 (122.2)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From initiation of first period (Day 1) to completion of last period (Day 98). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AMZ001 Low Dose	0 of 71 (0%)	7 of 71 (9.9%)	0 of 71
AMZ001 High Dose	0 of 72 (0%)	8 of 72 (11.1%)	0 of 72
Diclofenac Sodium 1% Gel	0 of 72 (0%)	5 of 72 (6.9%)	0 of 72

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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 in people with Healthy, run by Amzell at 1 site in United States.

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 6 inclusion and 22 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 9 Apr 2025. 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 United States. 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 9 Apr 2025). 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?

Compare Exposure to Diclofenac (time frame: Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05968482.

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 9 Apr 2025.