Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-24 @ 3:40 PM
NCT ID:
NCT06042192
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT06042192
Study Brief:
Protocol Section:
NCT06042192