EUCTR2015-003770-32-NL进行中（未招募）1 期
A Randomized, Double-Blind, Four Treatment, Four period, Crossover Study, with Placebo, Tizanidine Immediate Release and Diphenhydramine to Study the Effect of Tizanidine Extended Release on Simulated Driving Performance, Cognitive, and Psychomotor Functioning
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- 性别
- All
入选标准
- •-The potential participant has given informed and written consent and is able to comply with all study assessments scheduled in the protocol
- •-Healthy males or females aged 21 to 45 years (both inclusive) with body mass index between 18 and 30 kg/m2 and having normal vision
- •-Possession of a valid Netherlands driver’s license = 3 years with a reported average annual mileage = 5,000 km during the last 3 years
- •-Any female surgically sterile (bilateral tubal ligation at least 6 months prior, bilateral oophorectomy, or hysterectomy performed) or any female of child bearing potential should be willing to practice an acceptable method of birth control following screening to completion of study of the study. The acceptable contraceptive methods are condoms, diaphragm, intrauterine device (IUD), same sex partner or partner with vasectomy, (note: hormonal contraception is not permitted as it affects tizanidine pharmacokinetics)
- •-Potential subjects considered healthy based on medical evaluation, electrocardiogram and laboratory values at screening, all lab values are within normal limits or any value out of normal limits considered by the Investigator to be of no clinical significance
- •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
- •-History of allergies or hypersensitivity or intolerance to tizanidine or diphenhydramine
- •-History or presence of clinically significant or uncontrolled cardiovascular, neurological, psychiatric, hepatic, renal, gastrointestinal, hematological, musculoskeletal or sleep disorder
- •-History of surgery within 4 weeks of screening
- •-Clinical lab results suggestive of hepatic impairment (ALT or AST or bilirubin > 2 times of ULN) or renal impairment (creatinine > 2 mg/dL)
- •-Clinically significant history of alcohol intake (> 21 drinks per week).
- •-History of drug abuse with drugs used for recreational purpose within one year of the screening visit
- •-Use of any drug known to induce or inhibit hepatic drug metabolism (specifically CPY1A2 inhibitors, fluoroquinolones, zileuton, antiarrythmics, anti-histamines, ticlopidine, anti-virals, oral contraceptives, anti-depressants and any drugs known to cause change in neurological function) within 14 days of screening to end of study
- •-Signs or symptoms of narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy or bladder-neck obstruction
- •-History of participation in an investigational drug study within the past 30 days
- •-History of excessive caffeine consumption (> 5 cups/day) or smoking (=10 cigarettes per day) during the last six months prior to screening
- •-At admission for each period: evidence of pregnancy (urine pregnancy test positive on urine drug screen for women), or demonstrable blood-alcohol concentration (alcohol breath test)
- •-Pregnant or lactating females
研究者
相似试验
已完成
2 期
A Randomized, Double-Blind, Four Treatment, Four Period, Crossover Study, with Placebo, Tizanidine Immediate-Release and Diphenhydramine to Study Effect of Tizanidine Extended-Release on Simulated Driving Performance, Cognitive, and Psychomotor Functioninggezonde proefpersonenslaperigheid bij rijden na inname medicatiethe possible sedative effects of the medicationNL-OMON42658Sun Pharma Advanced Research Company (SPARC) limited24
已完成
不适用
To study the bioavailability and bioequivalence of four Ashwagandha extracts in healthy adultsCTRI/2020/10/028397Arjuna Natural Private Limited16
进行中（未招募）
不适用
A comparison study of LMTM and placebo in patients with Alzheimer’s Disease currently taking prespecified medicationsAlzheimer’s DiseaseMedDRA version: 14.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852EUCTR2011-005292-17-DETauRx Therapeutics Ltd60
进行中（未招募）
不适用
A comparison study of LMTM and placebo in patients with Alzheimer’s Disease currently taking pre-specified medicationsAlzheimer’s DiseaseMedDRA version: 14.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852EUCTR2011-005292-17-GBTauRx Therapeutics Ltd60
招募中
3 期
Clinical trial on Muscle strength and endurance in male subjects.CTRI/2024/07/071339KAPIVA