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

Title
Single-dose pharmacokinetics and dose proportionality of intravenous pazufloxacin mesilate in healthy Korean volunteers
Author(s)
임미선이주미[이주미]성숙진[성숙진]박성민[박성민]박정현[박정현]서정주[서정주]이혜원[이혜원]윤영란[윤영란]
Keywords
EXTENDED-RELEASE; QUINOLONE
Issue Date
201208
Publisher
INFORMA HEALTHCARE
Citation
EXPERT OPINION ON DRUG METABOLISM & TOXICOLOGY, v.8, no.8, pp.921 - 928
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 mu g/mL; the mean AUC(0-t) ranged from 13.70 to 58.60 mu g x 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.
URI
http://hdl.handle.net/YU.REPOSITORY/27551http://dx.doi.org/10.1517/17425255.2012.688951
ISSN
1742-5255
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약학대학 > 약학부 > Articles
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