EUCTR2014-000959-92-DK进行中（未招募）1 期
A randomized, double-blinded, Placebo controlled study of simvastatins possible effect on oxidative stress on healthy volunteers - SIMOX
Department of Clinical Pharmacology Q0 个研究点目标入组 40 人开始时间: 2014年4月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- Male
入选标准
- •Inc-1: caucasian
- •Inc-2: healthy male
- •Inc-3: between 18 and 50 of age
- •Inc-4: BMI between 18 and 30kg/m2
- •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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Ex-1: Total cholesterol less than 3 mmol/L
- •Ex-2: Use of natural and herbal medicines that is affected/affects simvastatin:
- •anionbyttere, amiodaron, amlodipin, ciclosporin, clarithromycin, colchin, danazol, diltiazem, erythromycin, fibrater, fluconazol, fusidine acid, grape fruitjuice, HIV protease inhibotors, itraconazol, ketoconazol, nefazodon, nicotinsyre (niacin), posaconazol, rifampicin, telithromycin, verpamil, vitamin K-antagonists, voriconazol
- •Ex-3 following diseases:
- •a Coronary vascular disease
- •b Renal insufficiency
- •c Hepatic insufficiency
- •d heart failure
- •e Previous heart arytmia
- •f Hypokalimia
- •g Low blood preassure
- •h hyperthyroidisme
- •i muscular toxicity
- •j galactose intolerens
- •k Lapp LActase deficiency
- •l Glucose/galactose-malabsorption
- •m Psykiatric disorder
研究者
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