| Eligibility |
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 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
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