ISRCTN35823260CompletedNot Applicable
Exploratory study to assess the cerebral bioavailability of Silexan® WS® 1265 standard softgel capsule and Silexan® WS® 1265 enteric-coated capsule using quantitative Electroencephalography (EEG) in healthy volunteers: a single-centre, randomised, double-blind, placebo-controlled, crossover study
Dr. Willmar Schwabe GmbH & Co. KG (Germany)0 sites48 target enrollmentStarted: March 18, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 48
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Male or female outpatients aged 18 to 65 years (both inclusive)
- •2. Written informed consent in accordance with the legal requirement
- •3. Readiness and ability on the part of the patient to comply with the physician?s instructions and to fill in the self-assessment scales
- •4. Negative pregnancy test within 7 days before baseline visit in women with childbearing potential (non-childbearing potential is defined as post-menopause for at least one year or surgical sterilisation or hysterectomy at least three months before the study starts)
- •5. Use of adequate double contraception in women with childbearing potential [oral or injectable contraception or hormonal intra-uterine system (IUS) combined with condom]
Exclusion Criteria
- •1. Participation in another clinical trial during the preceding 3 months
- •2. Pregnancy, lactation
- •3. Any acute medical disorder
- •4. History of relevant diseases of vital organs, of the central nervous system or other organs
- •5. Gastrointestinal disorders with uncertain absorption of orally administered drugs (e.g. partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, other disorders associated with chronic diarrhoea)
- •6. Subjects with a medical disorder, condition or history of such that would impair the subject?s ability to participate or complete this study in the opinion of the investigator or the sponsor
- •7. Known hypersensitivity to lavender preparations
- •8. Regular daily consumption of more than 25 cigarettes
- •9. Regular daily consumption of more than half litre of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form
- •10. Regular daily consumption of more than one litre of xanthin-containing beverages
- •11. Use of medication within the 2 weeks preceding the study which could interfere with the investigational product
- •12. Prohibited concomitant medication
- •13. Relevant deviation from the normal range in clinical chemistry, haematology or urinalysis
- •14. Resting heart rate in the awake subject below 45 beats per minute (BPM) or above 100 BPM
- •15. Systolic blood pressure below 90 mmHg for women and below 100 mmHg for men or above 150 mmHg
- •16. Diastolic blood pressure above 95 mmHg
- •17. History or evidence of alcohol and/or substance abuse or dependence, particularly of sedatives, hypnotics and anxiolytics within last 6 months before the study
- •18. Subjects testing positive in the drug screening
- •19. Participation in any previous clinical study with Silexan®/Lavender oil WS1265 or participation in a further clinical trial at the same time
- •20. Massive deviation from normal quantitativee electroencephalography (EEG) parameters
Investigators
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