EUCTR2017-002288-16-NL进行中（未招募）1 期
Effects of Modafinil and Caffeine during the circadian trough on vigilance in healthy RNLAF aircrew: a randomized controlled trial
Center for Man in Aviation0 个研究点目标入组 36 人开始时间: 2017年10月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
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
入选标准
- •I.The potential participant has given informed and written consent and is able to comply with all study assessments scheduled in the protocol.
- •II.All personnel need to be aircrew members of the Royal Netherlands Air Force, irrespective of their position.
- •III.All subjects need to be between 18 and 60 55 years of age.
- •IV.All subjects need to be in good health, and may not have any chronic diseases.
- •V.Subjects must have an electrocardiographic QTc time within normal limits
- •VI.Body Mass Index must be between 19 and 30 kg/m2
- •IV.VII.Subjects must be able to communicate, participate, and comply with the requirements of the entire study, including completion of all the visits along with the domiciled periods and sleep questionnaires.
- •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 36
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria are mostly based on possible side effects or interactions of one or both of the medicines.
- •i.Pregnant or nursing women are not eligible, modafinil is possibly teratogenic. There has not been enough research to prove modafinil safe for use during pregnancy.
- •ii.People with known heart, kidney or liver disease or neurological complaints are not eligible
- •iii.People who use medication that is being metabolized through CYP3A4/5, CYP2C19 of CYP2C9, since this might alter the plasma levels of the used medication and modafinil.
- •iv.A history of psychiatric illness disqualifies for the trials; this includes sleeping disorders
- •v.One week prior to starting every trial day, all subjects need to be (and remain) in a time zone that is a maximum of 4 time zones away from the CET time zone in which the research center lies. (GMT+1, daylight savings GMT+2). This to exclude jet lags that might confound the test results.
- •vi.Known allergies for caffeine, modafinil or any of its ingredients or metabolites.
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