This is a single site, open-label, single dose Phase 1 pharmacokinetic study of LP-001, an amoxicillin and clavulanate formulation, for use in pediatric patients between 3 and 24 months of age with a bacterial infection. 24 pediatric subjects will each receive a single dose of LP-001 in a fed state. 3 attempted blood draws per patient will be attempted up to 3 hours post dose.
The purpose of this study is to determine the pharmacokinetic profiles of LP-001, an amoxicillin and clavulanate formulation, for use in pediatric patients with a bacterial infection.