EUCTR2015-002265-36-NL进行中（未招募）不适用
A randomized, double blind, crossover, placebo controlled class-room experiment to assess the pharmacodynamics and pharmacokinetics of metoprolol in healthy volunteers with different polymorphism of CYP2D6
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相关药物
试验速览
- 阶段
- 不适用
- 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
- •Signed informed consent and willing to comply with the study restrictions
- •Healthy male or female subjects aged between 18 and 40 years
- •Non-smoking, with no clinically relevant abnormalities
- •Agree to abstain from caffeine (including coffee, tea, chocolate, or caffeine-containing soft drinks) intake from 24 hours prior to the first dose until the end of the study
- •The subject is willing and able to abstain from grapefruit, grapefruit juice or any other grapefruit-containing products for 72 hours prior to the first dose of study drug until the end of the study
- •Body weight greater than or equal to 45 kilogram (kg) at screening
- •Be able to refrain from strenuous physical exercise from 48 hours prior to each dosing period.
- •No significant ECG abnormalities.
- •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 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Concomitant clinical significant diseases at baseline, e.g., known cardiovascular or pulmonary disease, renal or liver dysfunction, ECG or laboratory abnormalities, etc.
- •Resting heart rate less than 45 bpm and blood pressure less than 105/60 millimeter of mercury (mmHg)
- •Have a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human peptides or proteins
- •Pregnancy or childbearing potential without adequate contraception
- •Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year
- •No blood donating or blood loss within 60 days prior to screening or plasma donating within 7 days prior screening.
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