Urinary amoxicillin-clavulanate concentrations in healthy female volunteers

This cross-over study involves a total of four visits at The Alfred hospital (two visits for dosing stage 1, and two visits for dosing stage 2), and a phone calls as follow up after each dosing stage. We will collect the following information for the project from participants: - Age (years) - Measured height (cm) and weight (kg) - Normal daily exercise regimen - Nicotine intake - Normal daily diet and fluid intake - Prior UTI history: number of UTIs in the past year, severity of symptoms, treatments received, and any hospitalisation - Concurrent medications: within 7 days prior to dosing stage 1 and dosing stage 2 - Concurrent supplements (probiotics, phyto therapeutics, cranberry products, vitamins): within 7 days prior to stage 1 and stage 2 dosing); including prior use of supplements within the past 12 months. - Prior use of any other antimicrobials in the last 12-months - Adverse reactions and allergies: known allergies and previous use of amoxicillin-clavulanate. You will receive two oral amoxicillin-clavulanate regimens on two separate days, provided by the study doctor, with at least 7 days between the two dosing stages (wash-out period): - Dosing Stage 1 (standard full dose): Amoxicillin-clavulanate as a dose of 875 mg amoxicillin and 125 mg clavulanate, three doses (3 tablets), over 24 hours You will then have a wash-out period of at least 7 days to clear the antibiotic from your system, before you can start dosing stage 2 (see comparator section for dosing stage 2). For the first dosing stage, the first two antibiotic tablets will be administered on-site under direct observation by the study team, with the time of dosing recorded. The third tablet will be taken at home at the scheduled time. Participants will be provided only with the exact number of tablets required for the study, and dosing times will be documented to support adherence monitoring. Participants will be asked to collect full urine voids over specific time-intervals during the study period, and get several blood samples drawn by research nurses. You will be asked to record voids, fluid and diet intake on provided sheet during the study period. You will be asked to record all entries immediately after urinating, drinking or eating to ensure accuracy. The follow-up phone call will be conducted by a member of the study team and is expected to last approximately 5 to 10 minutes.