EUCTR2012-004065-41-NL进行中（未招募）不适用
Comparative study of pharmacokinetics of amlodipine besilate oral liquid and tablets in healthy Dutch volunteers - Comparison of the pharmacokinetics of amlodipine besilate oral liquid and tablets
Erasmus Medical Centre0 个研究点开始时间: 2012年11月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •Subject is healthy
- •Subject is Caucasian
- •Age is between 18-55 years
- •Body Mass Index (BMI) is between 19-25
- •Written informed consent
- •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 12
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Sitting blood pressure lower than 120 mmHg systolic and/or 80 mmHg diastolic in resting conditions
- •Use of medication, both medicines on prescription and over-the-counter medicines, excluding contraceptives
- •Subject is familiar with one of the contra-indications of amlodipine: hypersensitivity to dihydropyridine derivatives, severe hypotension, shock (including cardiogenic shock), obstruction of the outflow tract of the left ventricle (e.g. aortic stenosis), hemodynamically unstable heart failure after acute myocardial infarction (16-17)
- •Allergy for one of the substances of both formulations
- •Subject has history of alcohol or drug abuse
研究者
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