Comparative pharmacokinetics study of two tablet formulations of delpazolid, a novel oxazolidinone class antibiotic.

ABSTRACT: Delpazolid is an oxazolidinone-class antibiotic under development for treating diseases caused by antimicrobial-resistant gram-positive bacteria. This study compared the pharmacokinetics (PK) and safety of two formulations of delpazolid 400 mg with distinct excipient compositions: Batch No. 3183817R (test drug) and Batch No. 1650006 (reference drug). A randomized, open-label, single-dose, two-way crossover study was conducted. The participants received a single oral dose of delpazolid 400 mg (test or reference) in each period, with serial blood samples collected up to 12 hours post-dose. The PK parameters of delpazolid were calculated using a noncompartmental method. The geometric mean ratios (GMRs) and its 90% confidence intervals (CIs) of the test drug to the reference drug were estimate

SUBMITTER: Koh J 

PROVIDER: S-EPMC11711391 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature