Bioequivalence of Domestic Ofloxacin Tablets in Chinese Healthy Volunteers

The aim of this research is to study the relative bioavailability of ofloxacin tablet in Chinese healthy volunteers and to evaluate the bioequivalence. METHODS: A single oral dose 200mg of domestic and imported ofloxacin tablets was given to 22 healthy volunteers in a randomized cross-over study. The concentrations of ofloxacin in serum and urine were determined by HPLC. Results: the main pharmacokinetic parameters of two formulations ,domestic and imported tablet, were as follows: t1/2b were 6.28±0.87 and 6.49±0.68 h; tmax were 0.86±0.26and 0.88±0.34h;Cmax were 2.61±0.53 and 2.75±0.52 mg·L-1;AUC0-1 were 15.54±1.80 and 15.60±1.42 mg·h·L-1;AUC1-∞ were 15.91±1.78 and 15.97±1.40 mg·h·L-1, respectively. The 36-hour cumulative urinary excretion rate were 75.12±7.82% and 74.77±8.15%,The relative bioavailability of AUC0-t was 99.75±8.73%.The results of ANOVA and two one-sided t test statistical analysis for In AUC0-∞ and InCmax showed that two formulations were bioequivalent. The 90% confidenceinterval of AUC0-t was 91.8%-105.9% was 75.0%-104.5%, then could evaluatethe two tablets were bioequivalent. CONCLUSION: The domestic and imported ofloxacin tablets were bioequivalent.