NCT01187862已完成1 期
Single-center, Randomized, Five-way Crossover Study to Investigate Low-dose Combinations of Caffeine, Efavirenz, Losartan, Omeprazole, Metoprolol, Chlorzoxazone and Midazolam ("Basel Cocktail") for Simultaneous Phenotyping of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4 in Healthy Male Subjects
University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2010年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Assessment of phenotyping measures of seven drugs used as a cocktail
研究概览
简要总结
The purpose of this study is to assess whether a cocktail of seven approved drugs (so-called "Basel cocktail") can be used for simultaneous phenotyping of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Male aged between 18 and 45 years
- •No clinically significant findings on the physical examination
- •Body mass index (BMI) between 18 and 28 kg/m2
- •Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and heart rate (HR) 45-90 bpm (inclusive)
- •12-lead electrocardiogram (ECG) without clinically relevant abnormalities
- •Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent
- •Negative results from urine drug screen
- •Ability to communicate well with the investigator and to understand and comply with the requirements of the study
排除标准
- •Known hypersensitivity to any excipients of the drug formulations
- •Treatment with another investigational drug within 30 days prior to screening
- •History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening
- •Excessive caffeine consumption, defined as mor than 800 mg per day
- •History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drug
- •Smoking within the last 3 months prior to screening
- •Previous treatment with any prescribed or OTC medications (including herbal medicines such as St John's Wort) within 2 weeks prior to screening
- •Loss of 250 ml or more of blood within 3 months prior to screening
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
- •Legal incapacity or limited legal capacity at screening
研究组 & 干预措施
Basel cocktail
Other
干预措施: caffeine, efavirenz, losartan, omeprazole, metoprolol, chlorzoxazone and midazolam (Drug)
结局指标
主要结局
Assessment of phenotyping measures of seven drugs used as a cocktail
次要结局
未报告次要终点
研究者
研究点 (1)
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