EUCTR2014-004554-34-DK进行中（未招募）1 期
An open label, explorative pharmacokinetic trial, to investigate the Cytochrome (CYP) CYP3A4, - 2E1 and – 1A2 clearance in Obese – versus Non Obese Children by use of well-tested probes (midazolam, chlorzoxazone, caffeine)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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
- •Obese children (BMI = 99 % percentile)
- •Healthy non-obese children (BMI= 90 % percentile)
- •Age 11-18 years
- •Both genders (block stratified)
- •Postmenarche (females)
- •Written informed consent from both parents (age<18)
- •Females included will be post menarche (Tanner stage 4) in order to avoid bias, as maturation of CYP1A2 activity mirrors pubertal growth, which peaks early in females.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 68
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Acute or chronic Liver diseases
- •Other chronic diseases, except from allergic rhinitis, rash etc.
- •Intake of drugs known to induce of inhibit CYP2E1-, CYP3A4 and/or CYP1A2, including paracetamol, ciprofloxacin, azithromycin, ketoconazol, estradiol etc.
- •Citrus fruit
- •Alcohol intake within minimum 72 hours
- •Caffeine (Coca Cola©, coffee and tea) intake 48 h prior to administration of the caffeine-probe
- •Smoking 96 hours prior to administration of the caffeine-probe, screening test will be performed (nicotine metabolite: cotinine)
- •Kidney disease and dialysis
- •Pregnancy (test will be performed)
- •Known hypersensitivity to chlorzoxazone, midazolam or caffeine
- •vigorous exercise 24 hours before administration
研究者
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