Assessment on pharmacokinetics and bioavailability of Gatifloxacin Capsules

Objective:To study pharmacokinetic parameters of two kinds of Gatifloxacin Capsules and assessment their bioavailability. Methods:An open, randomized, two-period crossover study was conducted in 36 healthy volunteers. Concentrations of gatifloxacin in plasma were assayed by HPLC after a single oral rose of 400 mg local Gatifloxacin Capsules or imported Gatifloxacin Capsules. The main pharmacokinetic parameters were analyzed by two one-sided t test. Results:Compared local Gatifloxacin Capsules, 90% confidence limit of AUCo-t and Cmax of imported Gatifloxacin Capsules was 95.8% times and 95.6% times, respectively. Conclusion:The Gatifloxacin Capsules has characteristic of quick absorption, high peak concentration in plasma and longer mean retention times. The restult of statistical analysis showed that two formulations were bioequivalent.