Bioequivalence study of two formulations of domestic sultamicillin in healthy volunteers

AIM:To evaluate the bioavailability of sultamicillin tablets from two companies.METHODS: Randomized,cross over designed trial conducted in 20 healthy volunteers.The plasma concentration of ampicillin and sulbactam were tested by reversed-phase high pressure liquid chromatography after a single oral dose of 750 mg tablets of study drug or reference drug.The pharmacokinetic parameters were calculated by pharmaceutic software named DAS.AUC and c_(max)were analyzed after logarithmic transform.RESULTS:The pharmacokinetic parameters of study drug vs reference drug were as follows:ampieillin c_(max),(10.8±s 1.9)mg·L~(-1) and(10.4±1.8)mg·L~(-1);t_(max), (0.68±0.14)h and (0.66±0.12)h;AUC_(0-t),(22±4)mg·h·L~(-1) and(22±4)mg·h·L~(-1);AUC_(0-∞),(24±5)mg·h·L~(-1)and(23±4)mg·h·L~(-1);t_(1/2),(1.07±0.26)h and(1.13±0.25)h;sulbactam c_(max),(7.4±1.3)mg·L~(-1) and (7.3±1.2)mg·L~(-1);t_(max),(0.66±0.12)h and(0.70±0.10)h;AUC_(0-t),(13.7±2.8)mg·h·L~(-1) and(13.2±2.3)mg·h·L~(-1);AUC_(0-∞),(14.2±2.9)mg·h·L~(-1)and(13.7±2.5)mg·h·L~(-1);t_(1/2),(0.97±0.19)h and(0.87±0.24)h. CONCLUSION:The two formulations of sultamicillin tablets are bioequivalent.