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:
2025-12-25 @ 3:15 AM
Ignite Modification Date:
2025-12-25 @ 3:15 AM
NCT ID:
NCT01047605
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female volunteers
* 30 - 70 years (extremes included)
* Medical history without any study relevant pathological findings
* Written and signed informed consent
Exclusion Criteria:
* Clinically study relevant acute or chronic disorders, that can be detected by clinical investigation or medical history
* Clinical, study-relevant pathological findings of clinical oar laboratory investigations
* Clinically relevant pathological EEG findings (e.g. artefact-free parts in Screening-EEG \<30% in one recording
* Clinically relevant allergies
* positive alcohol testing on Screening, Day A, B, or C, or anamnestic
* positive drug screening test on Screening, Day A, B, or C, or anamnestic
* Intake of study relevant medication 14 days prior to active Day A, or during active study duration, based on the volunteer´s information
* Regular intake of drug with primary central nervous effects (e.g. psychoactive drugs or central acting antihypertensive drugs)
* Known hypersensitivity / allergy against herbal extracts (i.e. dry extracts of Passionflower herb, St. John´s Wort herb, Valerian root) or lactose or an other excipient of the investigational medication
* Lapp-lactase deficiency (anamnestic)
* Hypersensitivity of the skin (anamnestic)
* BMI (Body-Mass-Index) \<18 or\>30
* Abuse of caffeine, teeine, or tobacco
* Smoking in the investigational site on Day A, B, or C
* Participation in an other clinical study within 60 days prior to Screening
* Positive Pregnancy Test (on Screening, Day A, B, or C) or Lactation
* Bad compliance
* Revocation of informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT01047605
Study Brief:
Protocol Section:
NCT01047605