A study to elucidate the effect of application conditions of a percutaneously absorbed type beta-1 blocker in healthy adults

Toa Eiyo Ltd.0 个研究点目标入组 12 人开始时间: 2016年6月6日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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.

•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

发起方