Pharmacokinetics and Bioequivalence of Gatifloxacin Dispersible Tablets in Human
Xingjie Guo
Abstract
Xingjie Guo
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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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