Bioequivalence of two commercial sultamicillin products in healthy subjects

Comparative serum levels of ampicillin and sulbactam were determined in six healthy male subjects after single oral administration of 2 x 375 mg test (Torrent formulation) and reference (Pfizer formulation) sultamicillin tablets in a double-blind cross-over study. The mean peak serum ampicillin concentration of 8.24 (g/ml was observed at 1.38 h from the test sultamicillin tablet and was similar to that of reference sultamicillin tablet. In case of sulbactam, the mean peak serum concentration of 7.50 (g[R1]/ml reached at 1.46 h from the test tablet and was insignificantly different than that of the reference tablet. The pharmacokinetic parameters of ampicillin and sulbactam from the test and reference sultamicillin tablets were comparable without significant variation. The mean relative bioavailability of ampicillin and sulbactam from the test sultamicillin tablets were 93.32 and 100.73%, respectively.