Flucloxacillin as an inducer of CYP-enzymes

niversity of Southern Denmark0 个研究点目标入组 14 人开始时间: 2020年10月27日最近更新: 2022年2月1日

试验速览

暂无简介。

•- Age 18-55 years
•- The following data have to be in the normal range or only clinical insignificantly different from this: eGFR, ALAT, bilirubin, HbA1c, haemoglobin
•- BMI 18.5 – 29.9 kg m-2
•- 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 14
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Known sensitivity to any of the used drugs or any excipients listed in section 6.1 in the Summary of Product Characteristics (SmPC)
•- Known allergy towards penicillin or cephalosporines
•- Any of the following diseases (current or previous): Heart disease, known family history of prolonged QTc interval, sudden death or conditions that might prolonged QTc-intervals, hypotension, severe disturbance of electrolyte balance e.g. hypokalemia or hypomagnesemia, myasthenia gravis, lung- or respiratory diseases, an anatomically abnormality of the respiratory tract, sleep apnea syndrome
•- Intake of any significant prescription drugs, over-the-counter drugs, herbal drugs or dietary supplements. Contraindicated drugs include: Benzodiazepines, beta blockers, ergot alkaloids, herbal preparations containing St. John’s wort, antiarrhythmics, neuroleptics, antidepressive agents, antibiotics, antifungal agents, non- sedating antihistamines, antimalarials, methadone, elbasvir, grazoprevir, nelfinavir cisapride, pimozide, bepridil
•- 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 units alcohol/week)
•- Women who are breastfeeding
•- Positive pregnancy test at inclusion screening or at any of the study days
•- Participation in any other interventional trials

发起方

niversity of Southern Denmark