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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07462559
Eligibility Criteria:
Inclusion Criteria:
* written informed consent
* age 18-45 years
* healthy
* no indications of substance abuse
* acceptable values in laboratory tests: hemoglobin must be at least at the lower limit of the reference range (men 134 g/l, women 117 g/l), liver values at most at the upper limit of the reference range (P -ALAT: women below 35 U/l, men below 50 U/l; P -AFOS: 35 U/l - 105 U/l; P -GT: women less than 40 U/l, men less than 60 U/l; P -Bil: less than 20 umol/l) and in other results (B -PVKT, P -Krea, P -K and P -Na) only minor values that deviate from normal values, which according to the examining physician's assessment are clinically insignificant. Drug screening (U -Huum-PS) and in women the pregnancy test (P-hCG-tot) should be negative.
* No significant abnormalities in the ECG
Exclusion Criteria:
* significant illness
* mood disorder or suicidality
* substance abuse
* systolic blood pressure over 150 mmHg
* conduction disorder or other significant abnormality in the ECG
* smoking
* regular medication, excluding contraceptives that do not contain estrogens
* pregnancy or its planning or breastfeeding
* less than 3 months from the previous clinical trial
* less than 3 months since donating blood
* significant overweight or underweight
* difficult to find elbow veins
* hypersensitivity to investigational drugs or excipients of medicinal products
* use of natural products (such as St. John's wort).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07462559
Study Brief:
Protocol Section:
NCT07462559