The effect of betahistine 48 mg three times daily on motion sickness - betahistine

TNO0 个研究点目标入组 26 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

暂无简介。

•Female volunteers should take oral contraceptives (combined or progestogen only). Body Mass Index (BMI) 18-28 kg/m2
•Healthy as assessed by health questionnaire (Pbetahistine F02; in Dutch) and a physical examination limited to auscultation of heart and lung, blood pressure and heart rate
•Susceptibility to motion sickness is more than 35 on Golding*s MSSQ scale.

•Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before Day 01 of this study
•Having a history of medical or surgical events that may significantly affect the study outcome
•Clinically relevant medical problems (vestibular, cardiovascular, pulmonary, gastrointestinal, neurological, psychiatric, hepatic, renal, hematological or other organic abnormality or pathology, including: asthma, ulcus pepticum urticaria, or allergic complaints as a rash or allergic rhinitis).
•Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study
•Subjects who are mentally handicapped.
•Subjects who have taken (non)prescription medications within the last 14 days, with the exception of painkillers such as aspirin, paracetamol, ibuprofen, up to 72 hours prior to the start of the study.
•Inclination to hyperventilation (Nijmegen questionnaire score > 23)
•Not able to undergo the familiarization tests inside the moving base-simulator Desdemona
•Alcohol consumption females > 21 or units/week; males >28 units/week
•Pregnancy or breastfeeding

发起方

TNO