A study to determine the pharmacokinetics of gatifloxacin following a single oral dose.

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dc.contributor.authorMandal, Uen_US
dc.contributor.authorMusmade, Pen_US
dc.contributor.authorGhosh, Aen_US
dc.contributor.authorChakraborty, Mitaen_US
dc.contributor.authorJayakumar, Men_US
dc.contributor.authorRajan, D Senthilen_US
dc.contributor.authorChakravarty, Men_US
dc.contributor.authorPal, T Ken_US
dc.contributor.authorChattaraj, T Ken_US
dc.contributor.authorRoy, Krishnangshuen_US
dc.contributor.authorBanerjee, S Nen_US
dc.date.accessioned2004-09-13en_US
dc.date.accessioned2009-05-31T18:35:56Z
dc.date.available2004-09-13en_US
dc.date.available2009-05-31T18:35:56Z
dc.date.issued2004-09-13en_US
dc.description.abstractGatifloxacin is a broad spectrum fluoroquinolone that offers enhanced Gram-positive activity and anaerobic coverage to other fluoroquinolones. The pharmacokinetic parameters (Cmax, AUCo-t, tmax) of this drug have been evaluated to compare the single dose (400mg) bioavailability of gatifloxacin with the reference formulation. High performance liquid chromatography (HPLC) coupled with U-V detector set at 290 nm has been used to determine plasma concentration of 12 human volunteers as per DCGI (Drug Controller General of India) guidelines. The method has been validated over a linear range of 0.25 to 8 microg/ml from plasma. The minimum quantifiable concentration has been set at 0.25 microg/ml (% CV < 10%). The pharmacokinetic parameters are: Cmax = 4.366 +/- 0.44 microg/ml at tmax = 1.83 +/- 0.44 hour, AUCO0-t = 25.26 +/- 2.91 microg hour/ml, AUCo-inf = 33.68 +/- 4.31 microg hour/ml, Kel = 0.094 +/- 0.024/hour and t1/2 = 8.0 +/- 1.92 hour.en_US
dc.description.affiliationBioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata 700032.en_US
dc.identifier.citationMandal U, Musmade P, Ghosh A, Chakraborty M, Jayakumar M, Rajan DS, Chakravarty M, Pal TK, Chattaraj TK, Roy K, Banerjee SN. A study to determine the pharmacokinetics of gatifloxacin following a single oral dose. Journal of the Indian Medical Association. 2004 Sep; 102(9): 488, 490, 492 passimen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/106019
dc.language.isoengen_US
dc.source.urihttps://www.jimaonline.org.in/en_US
dc.subject.meshAdministration, Oralen_US
dc.subject.meshAdulten_US
dc.subject.meshArea Under Curveen_US
dc.subject.meshBiological Availabilityen_US
dc.subject.meshCalibrationen_US
dc.subject.meshChromatography, High Pressure Liquiden_US
dc.subject.meshCross-Over Studiesen_US
dc.subject.meshFluoroquinolones --administration & dosageen_US
dc.subject.meshHumansen_US
dc.titleA study to determine the pharmacokinetics of gatifloxacin following a single oral dose.en_US
dc.typeClinical Trialen_US
dc.typeJournal Articleen_US
dc.typeRandomized Controlled Trialen_US
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