Objective To determine
enoxacin concentrations in human
plasma and study the pharmacokinetics and relative
bioavailability of enoxacin capsules. Methods A single dose 400 mg of reference and test enoxacin
capsules was given to 20 healthy volunteers in a randomized 2-way cross-over study. The plasma enoxacin concentrations were determined by HPLC. The pharmacokinetics as well as
relative bioavailability were measured. Results The main pharmacokinetic parameters of two formulations, reference and test drug were as follows: C max were (2.98±0.65) and (2.90± 0.63 ) mg·L -1 ,t max were(1.23±0.47) and (1.43±0.47)h,
AUC (0→24) were (18.20±4.60) and (19.71±4.31) mg·h·L -1 ;t 1/2Ke were (6.08±1.23) and (5.88± 0.89 )h. The relative bioavailability of AUC (0→24) and AUC (0-inf) was (112.0±26.7)% and (112.2±28.1)%,respectively.Using 3P97 program, the results of variance and two one-sided t-test statistical analysis for LnC max , LnAUC (0→24) and LnAUC (0-inf) showed that two formulations were bioequivalent. Conclusion The reference and test enoxacin capsules were bioequivalent.
More abstracts about the Relative bioavailability and bioequivalence of enoxacin capsules in healthy volunteers