Population pharmacokinetics of oral fosfomycin calcium in healthy women.

ABSTRACT:

Background

Fosfomycin is an antibiotic extensively used to treat uncomplicated urinary tract infections in women, and it is available in different salts and formulations. The European Medicines Agency (EMA) recommends further studies to characterize the pharmacokinetics of fosfomycin calcium for oral administration and to justify its dosage recommendation.

Objectives

A population pharmacokinetic model of fosfomycin calcium was developed after oral administration to healthy women.

Methods

A clinical trial (a randomized, open-label, bioavailability study of single and multiple doses of 1000 mg capsules, single dose of 500 mg capsule and single dose of 250 mg/5 mL suspension of oral fosfomycin calcium under fasted conditions in healthy women volunteers, Code: PD7522.22,

SUBMITTER: Isla A 

PROVIDER: S-EPMC11531824 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature