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临床试验/EUCTR2017-004852-52-AT
EUCTR2017-004852-52-AT进行中(未招募)1 期

The effect of Tetrahydrocannabinol on ocular hemodynamics in healthy subjects - ONH Blood Flow THC

Medical University of Vienna, Department of Clinical Pharmacology0 个研究点目标入组 24 人开始时间: 2018年3月6日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
24

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

  • Men and women aged between 18 and 35 years
  • Normal ophthalmic findings
  • Ametropia = 6 diopters
  • Normal findings in the medical history and physical examination including ECG unless the investigator considers an abnormality to be clinically irrelevant
  • Normal findings in the laboratory testing unless the investigator considers an abnormality to be clinically irrelevant
  • Nonsmokers
  • 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 24
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Regular use of medication, abuse of alcoholic beverages or drugs
  • History of drug or alcohol abuse
  • Psychiatric disorders in the medical history
  • Risk for drug dependence as evaluated by a psychiatrist
  • Participation in a clinical trial in the 3 weeks preceding the study
  • Positive urine drug test at the screening examination or on the study days
  • Positive alcohol breath test at the screening examination or on the study days
  • Regular consumption of cannabis and inability to not consume cannabis during the study period
  • Treatment in the previous 3 weeks with any drug (except intake of oral contraceptives)
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
  • Blood donation during the previous 3 weeks
  • Known hypersensitivity to any of the components of the IMP under investigation or other study medication
  • History or family history of epilepsy
  • Pregnant or breast-feeding women
  • Women of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant or condoms)

研究者

发起方
Medical University of Vienna, Department of Clinical Pharmacology

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