ArticleTranslational and clinical pharmacology2024
Comparative pharmacokinetics study of two tablet formulations of delpazolid, a novel oxazolidinone class antibiotic.
Article in Translational and clinical pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04939779 (A Randomized, Open-label, Single-dose, Two-way Crossover, Phase 1 Trial to Evaluate Bioequivalence of "LCB01-0371), which is not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Open-label, Single-dose, Two-way Crossover, Phase 1 Trial to Evaluate Bioequivalence of "LCB01-0371(Batch#1650006)" and "LCB01-0371(Batch#3183817R)" in Healthy Adult Subjects
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Authors and funding
5 authors.
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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 estimated for the maximum plasma concentration (C Trial Registration: ClinicalTrials.gov Identifier: NCT04939779.
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