A phase I, randomized, double-blind, placebo-controlled, ascending single- and multiple-dose study of the pharmacokinetics, safety, and tolerability of oral ceftibuten in healthy adult subjects.

ABSTRACT: This was a phase I, randomized, double-blind, placebo-controlled, ascending single- and multiple-dose study of oral ceftibuten to describe the pharmacokinetics (PK) of cis-ceftibuten (administered form) and trans-ceftibuten (metabolite), and to describe safety and tolerability at higher than licensed doses. Subjects received single 400, 600, or 800 mg doses of ceftibuten on Days 1 and 4, followed by 7 days of twice-daily dosing from Days 4 to 10. Non-compartmental methods were used to describe parent drug and metabolite PK in plasma and urine. Dose proportionality was examined using C _max, AUC_0-12, and AUC_0-INF. Accumulation was calculated as the ratio of AUC_0-12 on Days 4 and 10. Adverse events (AEs) were monitored throughou

SUBMITTER: Hernandez-Mitre MP 

PROVIDER: S-EPMC10777847 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature