作者
Aline Barth, Mohammad Hossain, Caroline R Perry, Annette S Gross, Hirofumi Ogura, Shaila Shabbir, Sebin Thomas, Etienne F Dumont, Darin B Brimhall, Meenakshi Srinivasan, Brandon Swift
发表日期
2023/1
期刊
Clinical Pharmacology in Drug Development
卷号
12
期号
1
页码范围
38-56
简介
Gepotidacin is a novel, bactericidal, first‐in‐class triazaacenaphthylene antibiotic in late‐phase development for uncomplicated urinary tract infection and uncomplicated urogenital gonorrhea. Two clinical studies were conducted to assess the pharmacokinetics (PK) and interethnic comparisons of oral gepotidacin (free‐base and to‐be‐marketed mesylate formulations) administered as single doses ranging from 1500 to 3000 mg in fed and fasted states, and as 2 × 3000‐mg doses given 12 hours apart under fed conditions in healthy participants of Japanese ancestry. Dose proportionality was observed in plasma exposures, and comparable area under the concentration‐time curve (AUC) and maximum concentration were observed in fed and fasted states. Interethnic comparisons for Japanese versus non‐Japanese participant data showed slightly higher plasma maximum concentration (7%‐30%) yet similar …
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