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临床试验/EUCTR2021-003814-37-DK
EUCTR2021-003814-37-DK进行中(未招募)1 期

The effect of dicloxacillin on oral absorption of drugs

Odense University Hosipital0 个研究点目标入组 12 人开始时间: 2021年8月18日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
12

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

  • - Age 18-55 years
  • - The following data must be in the normal range or only clinical insignificantly different from this: eGFR, ALAT, bilirubin, HbA1c, hemoglobin
  • - BMI >18.5 and < 30 kg/m2
  • - Bodyweight = 50 kg
  • - Non-smoker (abstained from smoking minimum 2 weeks before the first study day and during the trial)
  • - Generally healthy
  • - Willing to give 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

  • - Known sensitivity to any of the used drugs or any excipients listed in section 6.1 in the Summary of Product Characteristics (SmPC).
  • - Intake of any significant prescription drugs, over-the-counter drugs, herbal drugs, or dietary supplements*.
  • Contraindicated drugs include:
  • Anticoagulants, antiplatelet aggregation medicinal products, ticagrelor, clopidogrel, acetylsalicylic acid, chronic NSAIDs use, amiodarone, verapamil, systemic ketoconazole, clarithromycin, cyclosporin, itraconazole, tacrolimus, posaconazole, dronedarone, glecaprevir/pibrentasvir, quinidine, ritonavir, digoxin, selective serotonin reuptake inhibitors (SSRIs), selective serotonin norephinephrine reuptake inhibitors (SNRIs), pantoprazole, ranitidine, previous use of dicloxacillin or other P-gp or CYP450 inhibitors/inducers within 4 weeks prior to the start of treatment, probenecid, tetracycline, methotrexate
  • - Alcohol abuse or if the Danish Health Authority recommendation regarding alcohol intake has been exceeded 2 weeks before the first study day (men 14 units alcohol/week, women 7 unites alcohol/week)
  • - Participating in any other intervention trials
  • - A positive pregnancy test at inclusion screening or any of the study days
  • - Known penicillin allergy or reactions against cephalosporins, cephamycin, 1-oxa-ß-lactamer, or carbapenems
  • - Women who are breastfeeding
  • - Diagnosis of any of the following diseases (current or previous):
  • Mechanical heart valve, congenital or acquired coagulation disorders, thrombocytopenia or functional platelet defects, biopsy within 4 weeks, major trauma, bacterial endocarditis, esophagitis, gastritis, gastroesophageal reflux, active meningitis, encephalitis, intracranial abscess, undergoing surgery, liver disease, history of thrombosis or diagnosed with antiphospholipid syndrome, active cancer

研究者

发起方
Odense University Hosipital

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