Pharmacological Effects of Neurapas® Balance and Pascoflair® 425 mg on Brain Activity in Healthy Volunteers

Evaluation of the Pharmacological Effects of NEURAPAS® Balance and PASCOFLAIR® 425 mg by Quantitative Measurement of Brain Activity in 16 Healthy Volunteers. A Single-blinded, Randomised, Placebo-controlled, 3-armed Phase-I-study With Cross-over Design

To evaluate the pharmacological effects of two herbal medicinal products (Neurapas balance and Pascoflair 425 mg) in comparison to placebo on brain activity.

Evaluation of the pharmacological effects of Neurapas® balance and Pascoflair® 425 mg by quantitative measurement of brain activity in 16 healthy volunteers.

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