Pharmacokinetics of levofloxacin in healthy Thai male volunteers.

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dc.contributor.authorChulavatnatol, Sen_US
dc.contributor.authorChindavijak, Ben_US
dc.contributor.authorVibhagool, Aen_US
dc.contributor.authorWananukul, Wen_US
dc.contributor.authorSriapha, Cen_US
dc.contributor.authorSirisangtragul, Cen_US
dc.date.accessioned2009-05-27T20:29:35Z
dc.date.available2009-05-27T20:29:35Z
dc.date.issued1999-11-05en_US
dc.descriptionChotmaihet Thangphaet.en_US
dc.description.abstractThe pharmacokinetics of levofloxacin, a new fluoroquinolone, were investigated in 12 healthy Thai male volunteers with an average age (SD) of 22.92 (2.50) years. A single oral dose of 300 mg or 500 mg levofloxacin was given to subjects following an 8- hour overnight fast. The drug was given in a controlled, randomized, 2 x 2 crossover design with a 1 week washout period. Venous blood samples were drawn prior to and from 0.25 up to 48 hours after dosing. Plasma levofloxacin concentrations were determined by HPLC assay. The pharmacokinetics of levofloxacin were well described by a linear, 2-compartment open model with first-order absorption with lag time and first-order elimination. Mean +/- SEM of Cmax after 300 mg and 500 mg dose was 4.83 +/- 0.33 and 7.75 +/- 0.71 micrograms/mL, respectively. Tmax ranged from 0.7 to 0.8 hours for both doses. Mean +/- SEM of AUC0-infinity was 35.77 +/- 2.06 micrograms x h/mL for 300 mg dose and 61.57 +/- 2.84 micrograms x h/mL for 500 mg dose. High distribution with VSS/F value of approximately 1.5 L/kg was demonstrated after both doses. Mean +/- SEM of CL/F value was 8.64 +/- 0.41 L/h and 8.31 +/- 0.37 L/h for a 300-mg and a 500-mg dose, respectively. Long t1/2 beta of 7 to 8 hours with the mean residence time of 10.43 +/- 0.43 hours and 10.49 +/- 0.38 hours after 300 mg and 500 mg dose, respectively, was observed. The results suggested that an oral 300 mg dose once daily provides sufficient Cmax to cover most Gram-negative and atypical bacteria (median MIC90 0.032-0.5 microgram/mL) common in mild to moderate respiratory tract infections or complicated urinary tract infections and Gram-positive bacteria (median MIC90 0.5 microgram/mL) common in skin and soft tissue infections. For severe cases or Streptococcus pneumoniae (MIC90 2 micrograms/mL) infection, a 500-mg dose should be recommended.en_US
dc.description.affiliationDepartment of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand.en_US
dc.identifier.citationChulavatnatol S, Chindavijak B, Vibhagool A, Wananukul W, Sriapha C, Sirisangtragul C. Pharmacokinetics of levofloxacin in healthy Thai male volunteers. Journal of the Medical Association of Thailand. 1999 Nov; 82(11): 1127-35en_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/43097
dc.language.isoengen_US
dc.source.urihttps://www.mat.or.th/journal/all.phpen_US
dc.subject.meshAnti-Infective Agents --administration & dosageen_US
dc.subject.meshCross-Over Studiesen_US
dc.subject.meshHumansen_US
dc.subject.meshMaleen_US
dc.subject.meshMicrobial Sensitivity Testsen_US
dc.subject.meshOfloxacin --administration & dosageen_US
dc.titlePharmacokinetics of levofloxacin in healthy Thai male volunteers.en_US
dc.typeClinical Trialen_US
dc.typeJournal Articleen_US
dc.typeRandomized Controlled Trialen_US
dc.typeResearch Support, Non-U.S. Gov'ten_US
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