NDLI: Single-dose pharmacokinetics and dose proportionality of intravenous pazufloxacin mesilate in healthy Korean volunteers.

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Single-dose pharmacokinetics and dose proportionality of intravenous pazufloxacin mesilate in healthy Korean volunteers.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Lee, Joomi Seong, Sook Jin Lim, Mi-sun Park, Sung Min Park, Jeonghyeon Seo, Jeong Ju Lee, Hae Won Yoon, Young-Ran
Spatial Coverage	Republic of Korea
Description	Author Affiliation: Lee J ( Kyungpook National University Graduate School and Hospital, Department of Biomedical Science and Clinical Trial Center, Daegu, Republic of Korea.)
Abstract	OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
File Format	HTM / HTML
ISSN	17425255
Issue Number	8
Volume Number	8
e-ISSN	17447607
Journal	Expert Opinion on Drug Metabolism & Toxicology
Language	English
Publisher	Taylor & Francis
Publisher Date	2012-08-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Analytical Chemistry Discipline Pharmacology Dose-response Relationship, Drug Fluoroquinolones Administration & Dosage Pharmacokinetics Mesylates Oxazines Administration, Intravenous Adult Area Under Curve Asian Continental Ancestry Group Chromatography, High Pressure Liquid Blood Urine Humans Linear Models Male Republic Of Korea Young Adult Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Medicine Toxicology Pharmacology

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