Examining the pharmacokinetic and pharmacodynamic profile of biperiden - PK/PD biperiden

niversiteit Maastricht0 个研究点目标入组 42 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
•The participant has a body mass index of 18.5-30 kg/m2, inclusive, at medical screening.
•The participant is aged 18 to 35 years, inclusive, at the time of informed consent.
•The volunteer is healthy, i.e. absence of all exclusion criteria and had normal or corrected to normal static binocular acuity with or without correction.
•The participant signs and dates a written informed consent form before the start of the experiments.
•The participant has sufficient knowledge of the English language.

•The subject has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may impact the ability of the subject to participate or potentially confound the study results.
•The volunteer has uncontrolled existing major psychiatric symptoms.
•The participant has known hypersensitivity to any component of the formulation or biperiden or related compounds.
•The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the first visit or is unwilling to agree to abstain from alcohol from 24 hours prior to each test day and/or drugs throughout the study.
•The participant has any sensory or motor deficits which could reasonably be expected to affect test performance.
•Other exclusion criteria are smoking, excessive drinking (>20 glasses of alcohol containing beverages a week), pregnancy or lactation, use of medication other than oral contraceptives.

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