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 sites72 target enrollmentJanuary 11, 2016

DrugsLasea®Tavor

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Dr. Willmar Schwabe GmbH & Co. KG
Enrollment: 72
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 11, 2016

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Dr. Willmar Schwabe GmbH & Co. KG

Eligibility Criteria

Inclusion Criteria

•1\. Healthy male and female volunteers aged 25\-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\. Simulator training in the WIVW simulator passed with very good simulator tolerance.
•4\. Written informed consent in accordance with the legal requirements.
•5\. Readiness and ability of the volunteer to comply with the physician’s instructions and to fill in the self\-assessment scales.
•6\. 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 (i.e. less than 1% per year), such as implants, injectables, combined oral contraceptives, some intrauterinpessars, sexual abstinence or vasectomised partner).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 72

Exclusion Criteria

•1\. Participation in another clinical trial at the same time or within the past 4 weeks before enrolment.
•2\. Participation in the first study part described in the present outline excludes participation in the second study part.
•3\. Acute illness and/or infections and/or fever within the past 7 days prior to administration of IMP.
•4\. Increased intraocular pressure.
•5\. Chronic illness (specifically any psychiatric disorder according to DSM\-IV (e.g. Major depressive disorder, Anxiety disorder etc.) and neurological disorders (e.g. epilepsy, myasthenia gravis)).
•6\. 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).
•7\. \< 3 months before inclusion of the participant: use of psychoactive substances (specifically benzodiazepines, hypnotic non\-benzodiazepines like zopiclone or zolpidem, anxiolytics, tranquilizers, tri\- and tetracyclic antidepressants, neuroleptics/antipsychotics, lithium, carbamazepine as long\-term prophylactic treatment, treatment for neuro\-degenerative diseases).
•8\. \< 2 weeks before inclusion of the participant: use of centrally acting drugs like antihistaminics, anticonvulsants, any other antidepressants (including hypericum extracts), beta\-blockers, centrally acting antihypertensive medication (e.g. guanethidine, guanoxan, clonidine, prazosine, reserpine and alpha\-methyldopa), anti\-emetics, analgetics of opiate type, muscle relaxants, anaesthetics, OTC drugs with antidepressant, anxiolytic or hypnotic potential and others.
•9\. \< 3 months before inclusion of the participant: use of recreational drugs, e.g. CNS stimulants like amphetamines, cannabis, cocaine and others.
•10\. History or evidence of alcohol or drug abuse/dependence.