Objective To determine the relative
bioavailability and bioequivalence of
amoxicillin sodium/sulbactam sodium injection formulation
in healthy adult male volunteers. Methods In a randomized two-period cross-over study, 20 healthy volunteers were administrated intramuscularly single 1 500mg dose of
amoxicillin sodium/sulbactam sodium (test or reference formulation) . The plasma concentrations of amoxicillin and sulbactam were determined separately by a specific high-performance liquid chromatographic (HPLC) method. The pharmacokinetic parameters of the two preparations and the relative
bioavailability of amoxicillin sodium and sulbactam sodium injection after intramuscular injection were calculated with statistical analysis. Results Following intramuscular injection of the two preparations, the relative bioavailability (F) of amoxicillin and sulbactam in test were (103.3 ± 23.2)%; (104.0±16.2)%, respectively. There were no significant difference with the pharmacokinetic parameters between test and reference formulation (P>0.05). The 90% confidence interval of AUC0-t were 93.0%~109.8% (amoxicillin),96.5%~109.6% (sulbactam), Cmax were 90.8%~112.6% (amoxicillin), 95.2% ~ 115.1 %(sulbactam). Conclusion The two preparations were bioequivalent.