Safety profile and pharmacokinetics of 4-Fluoroamphetamine (4-FA)

Maastricht University0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•Previous experience with psychostimulants (≤ 1 time / week) and at least one time during the previous year • Age between 18 and 40 years • Free from psychotropic medication • The participant is in good health, in the opinion of the investigator, based on assessments of medical history, physical examinations, vital signs, electrocardiogram, and the results of haematology, clinical chemistry, urinalysis, serology, and other laboratory tests • Clinical laboratory test values within the reference ranges. Borderline values may be accepted if they are, in the opinion of the investigator, clinically insignificant. • Absence of any major medical, endocrine and neurological condition, as determined by the medical history, medical examination, electrocardiogram and laboratory analyses (haematology, clinical chemistry, urinalysis, serology) • Normal binocular visual acuity, corrected or uncorrected • Normal weight, body mass index (weight/height2) between 19,5 and 28 kg/m2 • Written Informed Consent

•History of drug abuse or addiction (determined by the medical questionnaire, drug questionnaire and medical examination) • Excessive drinking (> 20 alcoholic consumptions a week) • Pregnancy or lactation • Hypertension (diastolic> 90; systolic> 140) • Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination) • Liver dysfunction • (Serious) side effects to previous psychostimulant use • History of cardiac dysfunctions (arrhythmia, ischemic heart disease,…) • Simultaneous participation in another clinical trial • For women: not using reliable contraceptive • Blood donor

发起方