Can flucloxacillin affect other drugs effect?

Phase 1

• Conditions: Healthy volunteers.(Flucloxacillin is used against infections caused by beta-lactamase-producing organisms) Testing for drug-drug interactions caused by flucloxacillin; MedDRA version: 20.0Level: LLTClassification code 10004035Term: Bacterial infection due to staphylococcus aureusSystem Organ Class: 100000004862; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2020-004044-28-DK
• Lead Sponsor: niversity of Southern Denmark

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-27
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified