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

Completed

• Conditions: Anxiety disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN35823260
• Lead Sponsor: Dr. Willmar Schwabe GmbH & Co. KG (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-18
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified