Pharmacokinetics and Relative Bioavailability of Domestic Levofoxacin Distributive Tablet in Healthy Volunteers

OBJECTIVE:The pharmacokinetics and relative bioavailability of domestic levofoxacin distributive tablet in healthy volunteers were studied METHODS: A single oral 200mg dose of domestic levofoxacin distributive tablet or imported levofoxacin tablet was given to 12 healthy male volunteers in a randomized cross-over clinical study The serum concentrations of levofoxacin were determined by HPLC The pharmacokinetics parameters were analyzed by 3p97 computer software RESULTS:The serum concentration-time curve fitted to two compartment model,and the main pharmacokinetic parameters of domestic distributive tablet and imported tablet were as follows respectively Cmax=(1 14±0 29)mg/L and (1 18±0 31)mg/L,Tmax=(1 05±0 87)h and (1 04±0 83)h,AUC=(6 92±2 19)mg/(L·h) and (6 92±2 04)mg/(L·h) The relative bioavailability of domestic was (100 8±17 69)% There were no significant difference between the domestic distributive tablet and imported tablet CONCLUSION:The domestic distributive tablet and imported tablet are bioequivalent