EUCTR2015-001101-14-DE进行中（未招募）1 期
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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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.
- •11. Positive result in the drug screening or in the alcohol breath test at screening visit.
- •12. 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; mild seasonal hay fever is allowed as long as the season does not meet the study period.
- •13. Any clinically relevant laboratory value which the investigator decides might affect the study objectives.
- •14. Females who are breastfeeding.
- •15. Females who are pregnant (verified by a positive pregnancy test at screening visit).
- •16. Volunteers who are employees or direct relatives of an employee of the study centre or Dr. Willmar Schwabe GmbH & Co. KG.
- •17. Volunteers who are imprisoned or lawfully kept in an institution
- •18. Evidence or suspicion that the volunteer might not comply with the study directives and/ or that he/she is not reliable or trustworthy.
研究者
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