Effect of pharmacokinetic enhancers on flucloxacillin serum and urinary concentrations in healthy adults

niversity of Melbourne0 个研究点目标入组 20 人开始时间: 2023年11月8日最近更新: 2024年5月6日

试验速览

暂无简介。

•1. Body mass index (BMI) of 18.0 – 32.0 kg/m2 and body weight >= 50.0 kg.
•2. Medically healthy, determined by medical history, physical examination, non-clinically significant laboratory profiles, vital signs, and 12-lead ECG at screening, as deemed by the Investigator.
•3. Females must be non-pregnant, non-lactating, or postmenopausal for at least 1 year or surgically sterile for at least 6 months prior to dosing.
•4. If relevant, non-pregnant female participants will be required to use an effective form of contraception from 28 days prior to the study until the end of study.
•5. Males must not have a pregnant partner and must agree to use condoms as a method of contraception from the time of signing informed consent until the end of study.

•1. History of any clinically important cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
•2. Significant history of hospitalization for illness within the six months prior to enrolment into the study, or major surgery within the 12 months prior to enrolment into the study, as assessed by the study physician or investigator.
•3. A contraindication or significant risk associated with the use of either of IMPs.
•4. Likely to have altered drug exposures.
•5. Other health risks as determined by the study physician.

发起方

niversity of Melbourne