DRKS00023352已完成1 期
Pharmacokinetic profile of betahistine blood concentration with and without selegiline in healthy volunteers - a mono-center, open-labeled phase I trial - PK-BeST
MU Klinikum Neurologische Klinik und Poliklinik0 个研究点目标入组 15 人开始时间: 2020年10月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •healthy volunteers (age = 18 years and = 70 years) as determined by screening and Principal Investigator's judgement
- •no intake of medication due to an illness
- •written informed consent of the subject
- •systolic blood pressure between 90 and 140 mmHg and diastolic blood pressure between 60 and 90 mmHg at screening
- •PQ interval in the ECG between 0.12 s and 0.20 s
- •duration of the QRS complex between 0.06 s and 0.10 s
- •QTc intervall 440 ms or less
- •heart rate between 60 and 100 beats per minute
- •subjects with the ability to follow study instructions and likely to attend and complete all required visits
排除标准
- •subject is not able to give consent
- •a condition in which repeated blood draws or injections pose more than minimal risk for the subjects, such as hemophilia, other severe coagulation disorders or significantly impaired venous access
- •participation in another study with an investigational drug or device within the last 30 days, prior participation in the present study, or planned participation in another trial
- •intake of medication due to an illness
- •subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk, may confound the trial results, or may interfere with the subject's participation in the clinical trial
- •current or planned pregnancy or nursing woman
- •woman of childbearing potential who are not willing to use medically reliable methods of contraception for the entire study duration
- •intake of alcohol 24 hours before first IMP intake or during study participation
- •known or persistent abuse of medication, drugs or alcohol (positive test for alcohol or drugs)
- •known contraindications of betahistine, such as bronchial asthma, pheochromocytoma, treatment with antihistaminic drugs, ulcer of the stomach or duodenum, severe dysfunction of liver or kidney,hypersensitivity to betahistine or other ingredients
- •known contraindications to selegiline, e.g. use of opioids, tricyclic antidepressants, sympathomimetics, non-selective MAOIs, (selective) serotonin (-noradrenaline) re-uptake inhibitors (SSRI/SNRI), serotonin agonists, hypersensitivity to selegiline or other ingredients
- •hereditary intolerance of galactose, hereditary deficiency of lactose, glucose-galactose-malabsorption
- •AV Block in the ECG
- •hypotonic or hypertonic subjects according to the criteria of the National Heart, Lung and Blood Institute (Hypertension >140/90 mmHg, Hypotension <90/60 mmHg)
研究者
相似试验
已完成
1 期
Pharmacokinetic Profile of Betahistine With and Without Selegiline in Healthy VolunteersMénière's DiseaseNCT05938517Ludwig-Maximilians - University of Munich15
已完成
不适用
Comparative fasting bioavailability of 2 different betahistine dihydrochloride 24-mg tablets: a single-dose, randomized-sequence, open-label, 2-period crossover study in healthy Thai volunteers.healthy volunteersbetahistine dihydrochlorideBioequivalenceTCTR20151106002Somruedee Chatsiricharoenkul24
已完成
不适用
Efficacy of high dosage of betahistine in patients with unilateral peripheral vestibulopathyunilateral peripheral vestibulopathyJPRN-UMIN000017711niversity of Tokushima225
招募中
不适用
Effect of betahistine in treating in patients with peripheral vestibular diseaseperipheral vestibular diseaseJPRN-UMIN000032573niversity of Toyama15
进行中（未招募）
不适用
The effect of betahistine 48 mg three times daily on motion sickness - betahistineEUCTR2008-000885-21-NLTNO