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

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• 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 p