Open Label Trial to Evaluate the Adhesion of TK-254RX in Healthy Volunteers.
Healthy
About this trial
This is an interventional treatment trial for Healthy
Eligibility Criteria
Inclusion Criteria: age: 18 to 64 years good state of health non-smoker or ex-smoker for at least 3 months written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial Exclusion Criteria: The following must not apply: any injury of body which may induce the restriction of body movement excessively hairy skin at application site current skin disorder or shaving hair at application site history of excessive sweating/hyperhidrosis inclusive of application site participation in a clinical study within 30 days before inclusion in the study or concomitantly drug or alcohol abuse in the opinion of the investigator pregnant and lactating women women of child-bearing potential who do not agree to apply highly effective contraceptive methods known hypersensitivity to active ingredient, its racemate or one of the excipients of the TK-254RX existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient known liver or kidney insufficiency existing gastrointestinal diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders systolic blood pressure < 90 or > 139 mmHg diastolic blood pressure < 60 or > 89 mmHg pulse rate < 50 bpm or > 90 bpm subjects who use any impermissible medication
Sites / Locations
- Medical Practice Ebert
- Medical practice Pabst
- Medical practice Gastl
- Medical Pracitice Schaale/Bücheler
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
TK-254RX applied to Lower Arm, Lower thigh or Ankle
TK-254RX applied to Upper Arm, Upper thigh or Lower leg
For Group1, TK-254RX will be applied to left and right side (total of two TK-254RX per day) of the following predetermined application site by subjects. Day1: Lower Arm, Day2: Lower thigh, Day3: Ankle
For Group2, TK-254RX will be applied to left and right side (total of two TK-254RX per day) of the following predetermined application site by subjects. Day1: Upper Arm, Day2: Upper thigh, Day3: Lower leg