EUCTR2006-004396-35-GB进行中（未招募）1 期
Investigation of the anti-inflammatory effects of simvastatin in a model of acute lung injury after inhalation of lipopolysaccharide by healthy volunteers - Statins in a model of acute lung injury in healthy volunteers
Belfast City Hospital Trust0 个研究点开始时间: 2006年9月18日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Healthy non-smoking subjects
- •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
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •age < 18 years
- •creatinine kinase (CK) > 5 times upper limit normal range
- •known active liver disease, alcohol abuse or abnormal liver function tests: transaminases > 3 times upper limit normal range
- •renal impairment (calculated creatinine clearance less than 60mL/minute)
- •known lactose intolerance
- •history of asthma
- •participation in other trials within 30 days
- •pregnancy, breast-feeding or women of childbearing potential not using adequate contraception;
- •current treatment with statins
- •known hypersensitivity to the study medication
- •a previous adverse reaction to statins
- •concomitant use of fibrates or other lipid-lowering therapy
- •concomitant use of itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, grapefruit juice, cyclosporine, danazol, amiodarone, verapamil or diltiazem .
- •consent declined
研究者
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