Healthy adult
Conditions
Interventions
One sheet of the study formulation is once applied to the chest for 24 hr
One sheet of the study formulation is once applied to the calf for 24 hr
One sheet of the study formulation is once applied to
Sponsors
Toa Eiyo Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1,Healthy male Japanese aged from 20 to 35 years old (at acquisition time of informed consent). 2,The person whose BMI [weight [kg]/(height [m])2] is 18.5 or more but less than 25.0 (cut off at 2 decimal places). 3,The person who is judged to be eligible as the study subjects for this study by a principal investigator or an investigator in charge of this study by taking into account the backgrounds of volunteers obtained in screening tests (medical history, allergy, favorite food and drinks, etc.), physical findings, results of physiological test, clinical examination values, etc.
Exclusion criteria
Exclusion criteria: 1.Having disease to be cured now 2.Having drug/cutaneous allergy or its PH 3.Having disease affecting drug ADME in GIT, heart, liver, & kidney, or its PH 4.Having allergic diseases like asthma, pollen disease now 5.SBP is <90 mmHg or pulse rate <55/min at screening 6.Having PH of skin rash by external drugs 7.Having cutaneous diseases (e.g., dermatitis, pigment deposition, external injury) preventing from assessing effect at dose site 8.Having skin hair preventing from securing dose site, having tattoo/birthmark at the site, or often making sunburn his skin 9.Giving 400 mL oe more of WB within 12 W before dosing, giving 200 mL or more of WB or having such a plan within 4 W before dosing, or giving blood components or having such a plan within 2 W before dosing 10.Using a drug except said test drug or having such a plan within 1 W before dosing (except artificial tears) 11.Participating in another study and receiving a study drug or having such a plan within 16 W before dosing (within 4 W in a patch test) 12.Positive to any of immunological test item/deviating from its standard laboratory values at screening 13.Judged as undesirable as subject by principal investigator or investigator charged
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Calculate pharmacokinetic parameters by application site and by application duration. Parameters to be calculated: AUC24, Cmax, Tmax, t1/2, etc. | — |
Secondary
| Measure | Time frame |
|---|---|
| Calculate the remaining amount and remaining ratio of the drug in a formulation by application site and by application duration. In addition, calculate the released amount and released ratio of the drug from the formulation. | — |
Countries
Japan
Outcome results
None listed