Bioequivalence of levofloxacin hydrochloride oral liquid in healthy volunteers

Objective To study the relative bioavailability of levofloxacin hydrochloride oral liquid and tablets in healthy volunteers. Methods In a randomized two- way crossover design,a single oral dose of 200mg levofloxacin hydrochloride oral liquid and tablets were given to 24 male healthy volunteers.The plasma levofloxacin concentration within 36 h after administration was determined by HPLC and parameters C_(max),T_(max),T_(1/2),AUC_((0-1)),AUC_((0-∞)) were obtained and analyzed by two- one side test.Results The C_(max) were(2.80±0.59) and(2.64±0.56)μg /ml,respectively;T_(max) were(0.66±0.18 ) and(0.82±0.34) h,respectively;T_(1/2) were (6.60±1.37)and(7.26±1.20) h,respectively;AUC_((0-t)) were(14.97±2.32)μg.h/ml和(15.04±2.32)μg·h/ml,AUC_((0-∞)) were(15.66±2.38 ) and(15.92±2.35 )μg.main pharmacokinetic parameters of levofloxacin hydrochloride oral liquid and tablets were as follows:C_(max) was(2.80±0.59) and(2.64±0.56)μg/ml,respectively;T_(max) was(0.66±0.18) and(0.82±0.34) h,respectively; T_(1/2) was(6.60±1.37) and(7.26±1.20) h,respectively;AUC_((0-t)) was(14.97±2.32)μg·h/ml and(15.04±2.32)μg·h/ml,respectively.AUC_((0-∞)) was(15.66±2.38) and(15.92±2.35)μg·h/ml,respectively.There was no statistically significant difference between these two test groups.The relative bioavailability of the test oral liquid was(100.1±10.6)%.Conclusions The levofloxacin hydrochloride oral liquid and tablets are bioequivalent.