Pharmacological Effects of Neurapas® Balance and Pascoflair® 425 mg on Brain Activity in Healthy Volunteers (NCAG 5209)

• Comparison PP1 vs PP2 vs Placebo: Z2: qEEG (all frequencies, Clusters): Median change of electrical activity (qEEG: of selective brain-regional clusters of electrode positions) compared to Baseline [ Time Frame: 5 times within 4 h ] [ Designated as safety issue: No ]
• Comparison PP1 vs PP2 vs Placebo: Z3:qEEG (d2, beta1 (Cluster F7/T3)) [ Time Frame: 5 times wihtin 4 h ] [ Designated as safety issue: No ]
• Comparison PP1 vs PP2 vs Placebo: Z4:qEEG (ME, theta (Cluster F7/T3/T6)) [ Time Frame: 5 times within 4 h ] [ Designated as safety issue: No ]
• Comparison PP1 vs PP2 vs Placebo: Z5:qEEG (KLT, theta (Cluster F7/T3) + alpha (Cluster T4/T6)) [ Time Frame: 5 times within 4 h ] [ Designated as safety issue: No ]
• Comparison PP1 vs PP2 vs Placebo: Z6: qEEG (Aa, all frequencies, Cluster C3/T3/P4) [ Time Frame: 5 times within 4 h ] [ Designated as safety issue: No ]
• Comparison PP1 vs PP2 vs Placebo: Z7: Timely onset of effect and duration of effect [ Time Frame: 5 times within 4 h ] [ Designated as safety issue: No ]

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.

• Drug: Neurapas balance
  6 tablets single dose
• Drug: Pascoflair 425 mg
  3 tablets , single dose
• Drug: P-Tabletten weiß
  3 tablets, single dose

• Experimental: PP1
  Neurapas balance
  Intervention: Drug: Neurapas balance
• Experimental: PP2
  Pascoflair 425 mg
  Intervention: Drug: Pascoflair 425 mg
• Placebo Comparator: PL1
  P-Tabletten weiß
  Intervention: Drug: P-Tabletten weiß

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