Single-dose pharmacokinetics and dose proportionality of intravenous pazufloxacin mesilate in healthy Korean volunteers
Autor: | Young-Ran Yoon, Jeonghyeon Park, Jeong Ju Seo, Mi-sun Lim, Joomi Lee, Sook Jin Seong, Hae Won Lee, Sung Min Park |
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Rok vydání: | 2012 |
Předmět: |
Adult
Male Cmax Urine Pharmacology Toxicology Young Adult chemistry.chemical_compound Asian People Dose proportionality Pharmacokinetics Oxazines Republic of Korea Pazufloxacin Humans Medicine Chromatography High Pressure Liquid Mesylates Intravenous dose Dose-Response Relationship Drug business.industry Parallel study General Medicine chemistry Tolerability Area Under Curve Linear Models Administration Intravenous business Fluoroquinolones |
Zdroj: | Expert Opinion on Drug Metabolism & Toxicology. 8:921-928 |
ISSN: | 1744-7607 1742-5255 |
DOI: | 10.1517/17425255.2012.688951 |
Popis: | The aim of this study was to investigate the pharmacokinetics and dose proportionality of a single, intravenous dose of pazufloxacin mesilate, an injectable fluoroquinolone antibiotic, in healthy Korean male volunteers.In this open-label, four-dose, parallel study, subjects were randomized to receive a single dose of pazufloxacin mesilate 300, 500, 600, and 1,000 mg (n = 6, 20, 6, and 8, respectively) administered as a 1-h intravenous infusion. Blood and urine samples were collected serially from 0 to 24 h after drug administration and analyzed using a validated HPLC method. Tolerability was assessed by monitoring clinical laboratory parameters and adverse events.After single-dose intravenous administration of pazufloxacin mesilate, the mean C(max) for groups treated with 300, 500, 600, and 1,000 mg doses ranged from 5.11 to 18.06 μg/mL; the mean AUC(0-t) ranged from 13.70 to 58.60 μg × h/mL. Pazufloxacin exhibits Lack of dose proportionality was concluded over the dose range of 300 - 1,000 mg, based on linear regression model and power model . At all four dosages studied, pazufloxacin mesilate was well tolerated.Our data suggest that all regimens of pazufloxacin administration were well tolerated. Pazufloxacin exhibits lack of dose proportionality over the dose range of 300 - 1,000 mg. |
Databáze: | OpenAIRE |
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