Bioequivalence of levofloxacin capsule and tablet in human

OBJECTIVE Compared with levofloxacin tablet to evaluate the relative bioavailability and bioequivalence of levofloxacin capsule. METHOD 8 male health volunteers orally took a single dose of 200mg levofloxacin capsule and tablet in cross ways. The plasma concentrations of levofloxacin were determined by RP-HPLC.RESULTS The pharmacokinetic parameters of levofloxacin capsule and tablet were as follows: AUC 0-24 (8802.41±1728.39)ng·h·mL -1 and (9097.25±1558.40)ng·h·mL -1; C max (2042.31±697.19)ng·mL -1 and (1751.01±400.42)ng·mL -1; t max (0.66±0.19)h and (0.84±0.53)h; MRT (8.15±1.33)h and (9.03±1.16)h; t 1/2β (6.52±0.78)h and (6.79±0.74)h, respectively. There was no statistical difference between levofloxacin capsule and tablet in pharmacokinetic parameters (P0.05). The relative bioavailability of levofloxacin capsule was (96.77±8.88)%. CONCLUSION Two preparations of levofloxacin are bioequivalent.