2008•Chinese Journal of PharmaceuticalsRequires access

Pharmacokinetics and Bioequivalence of Gatifloxacin Dispersible Tablets in Human

Xingjie Guo

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Abstract

A single dosage 400mg by randomized cross-over design was used to investigate the pharmacokinetics and bioequivalence of gatifloxacin dispersible tablets (test preparation) and tablets (reference preparation) in 20 healthy volunteers after oral administration. The drug concentration in plasma was determined by HPLC. The main pharmacokinetic parameters of the test and reference preparations were as follows: AUC0→t (35.51±4.87) and (36.38±4.50) μg·h·ml-1, cmax (4.48±0.89) and (4.60±0.86) μg/ml, tmax (0.85±0.38) and (0.94±0.38)h, respectively. The relative bioavailability of the test preparation was (98.5±15.4)%. The result indicated that the two preparations are bioequivalent.

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What this paper is about

A single dosage 400mg by randomized cross-over design was used to investigate the pharmacokinetics and bioequivalence of gatifloxacin dispersible tablets (test preparation) and tablets (reference preparation) in 20 healthy volunteers after oral administration. The drug concentration in plasma was determined by HPLC. The main pharmacokinetic parameters of the test and reference preparations were as follows: AUC0→t (35.51±4.87) and (36.38±4.50) μg·h·ml-1, cmax (4.48±0.89) and (4.60±0.86) μg/ml, tmax (0.85±0.38) and (0.94±0.38)h, respectively. The relative bioavailability of the test preparation was (98.5±15.4)%. The result indicated that the two preparations are bioequivalent.

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Available abstract

A single dosage 400mg by randomized cross-over design was used to investigate the pharmacokinetics and bioequivalence of gatifloxacin dispersible tablets (test preparation) and tablets (reference preparation) in 20 healthy volunteers after oral administration. The drug concentration in plasma was determined by HPLC. The main pharmacokinetic parameters of the test and reference preparations were as follows: AUC0→t (35.51±4.87) and (36.38±4.50) μg·h·ml-1, cmax (4.48±0.89) and (4.60±0.86) μg/ml, tmax (0.85±0.38) and (0.94±0.38)h, respectively. The relative bioavailability of the test preparation was (98.5±15.4)%. The result indicated that the two preparations are bioequivalent.

Key concepts: Bioequivalence, Pharmacokinetics, Cmax, Bioavailability, Gatifloxacin, Chemistry, Chromatography, Pharmacology

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