DRKS00017448招募中1 期
Systematic determination of the pharmacokinetic interactions of Echinacea purpurea with prescribed medications in healthy volunteers: A phase-I clinical trial using a cocktail approach - EchinaceaDDI
niversitätsklinikum Schleswig-Holstein (UKSH)0 个研究点目标入组 49 人开始时间: 2020年1月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 49
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 54 Years（—）
- 性别
- All
入选标准
- •1. Subject gives informed consent by means of a personally signed and dated informed consent form (ICF)
- •2. Age 18-54 years
排除标准
- •2.Participants who are genetically carriers of CYP2D6*3-6/*3-6, CYP2C9*2/*3 or *3/*3, CYP3A*22, CYP2C19*2/*2 or SLCO1B1*5/*5
- •3.Subjects currently enrolled in another clinical trial
- •4.Usage of medicinal products (prescription and OTC) during the study period, excluding non-hormonal contraceptives
- •5.Consumption of grapefruit and bitter orange during the study period
- •6.Consumption of alcohol, tea, herbal supplements or caffeine within 24 hours prior to and during each in-patient study day
- •7.Hypersensitivity, allergy or idiosyncratic reaction to the IMPs
- •8.Specific contraindication to the IMPs not covered by other exclusion criteria:
- •8.1.History of apnoea/respiratory insufficiency (midazolam, codeine)
- •8.2.History of myopathy (pitavastatin, rosuvastatin)
- •8.3.History of immune disorders/atopy or tuberculosis/sarcoidosis (Echinacea)
- •8.4.Known CYP2D6-ultra-rapid-phenotype (codeine)
- •8.5.Known risk factors for bleeding like gastrointestinal lesions, recent neurosurgery or damages to brain/spine, oesophageal varices, arteriovenous malformations (dabigatran)
- •9.History of coagulation disorders, abnormal clotting lab results or pharmaceutical anti-coagulation
- •10.Estimated Glomerular Filtration Rate < 80 ml/min
- •11.Known active hepatitis B or C infection, acute liver malfunction or abnormal liver lab results
- •12.Elevated creatinine kinase (as judged by the investigator)
- •13.Persistent diarrhea
- •14.Pregnancy and breastfeeding
- •15.Any other disease, condition or safety laboratory result which might compromise significantly the hematopoietic, renal, pulmonary, hepatic, cardiovascular, immunological, central nervous, dermatological, endocrinological or psychiatric or any other body system (as judged by the investigator)
- •16.Expected or suspected non-compliance, e.g., major cognitive or psychiatric disorders, drug usage
- •17.Subjects who are scheduled to undergo hospitalization during the study period
- •18.Legal incapacity
- •19.Women of child-bearing potential and not on highly-effective (Pearl-Index <1%) non-hormonal contraception
- •20.Medical students who are before or in a semester with pharmacological courses and examination at Kiel University
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