Study of the Pharmacokinetics and Bioequivalence of Gatifloxacin Dispersible Tablets in Chinese Healthy Volunteers

OBJECTIVE To study the pharmacokinetics and relative bioavailability and bioequivalence of Gatifloxacin dispersible tablets in healthy volunteers.METHODS A single oral dose(400 mg of tested and reference formulation) was given to 20 healthy volunteers in a randomised crossover study.The concentrations of Gatifloxacin in plasma were determined by HPLC.The pharmacokinetics parameters were calculated and the bioavailability and bioequivalence of two formulations were evaluated by DAS program.RESULTS After a single dose,the pharmacokinetics parameters for gatifloxacin were as follows: Cmax were(3.75±0.74)mg·L-1 and(3.88±0.7) mg·L-1;Tmax were(0.81±0.31)h and(1.31±0.55)h;AUC(0-24) were(18.48±3.69)mg·h·L-1 and(18.45±2.67)mg·h·L-1;AUC(0-inf) were(19.24±3.64)mg·h·L-1 and(19.20±2.66)mg·h·L-1 for T and R respectively.The 90% confidential interval of AUC(0-24),AUC(0-inf) and Cmax of tested formulation were 91.8%-107.2%,92.1%-107.2%,90.4%-103.0%.CONCLUSION The relative bioavailability was(101.01±19.26)%;The results of the statistic analysis showed that the two formulations were bioequivalent.