Driving fitness under acute and subchronic application of Silexan® (WS® 1265) in comparison to placebo and Lorazepam with healthy volunteers in two successive, randomized, double-blind, crossover designed trial parts

Dr. Willmar Schwabe GmbH & Co. KG0 个研究点目标入组 201 人开始时间: 2016年3月30日最近更新: 2020年6月29日

试验速览

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•1. Aged 25 to 60 years
•2. Active drivers that have had a driver’s license for at least 3 years and have a minimal mileage per year of 3000 km
•3. Written informed consent
•4. Only for female volunteers who have not entered menopause and who are not sterilized: Using a highly effective method of birth control that has a very low failure rate

•1. Participation in another clinical trial at the same time or within the past 4 weeks before enrolment
•2. Acute illness and/or infections and/or fever within the past 7 days prior to administration of IMP
•3. Increased intraocular pressure
•4. Chronic illness
•5. Gastrointestinal disorders with uncertain absorption of orally administered drugs
•6. < 3 months before inclusion of the participant: use of psychoactive substances
•7. < 2 weeks before inclusion of the participant: use of centrally acting drugs
•8. < 3 months before inclusion of the participant: use of recreational drugs, e.g. CNS stimulants like amphetamines, cannabis, cocaine and others
•9. History or evidence of alcohol or drug abuse/dependence
•10. Positive result in the drug screening or in the alcohol breath test at screening visit
•11. Presence or history of clinically relevant allergy or a known or suspected hypersensitivity to lavender oil, Lorazepam and/or excipients of the IMP or benzodiazepines
•12. Any clinically relevant laboratory value which the investigator decides might affect the study objectives
•13. Females who are breastfeeding or who are pregnant

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