Pharmacokinetics and Relative Bioavailability of Clindamycin Phosphate Capsules in Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE:To study the pharmacokinetics and relative bioavailability of clindamycin phosphate capsules in healthy volunteers METHODS:A single oral dose of 300mg domestic clindamycin phosphate capsules or imported Dalacin C was given to 18 healthy male volunteers in an open randomized crossover study Clindamycin concentrations in plasma were determined by microbiologic assay The pharmacokinetic parmameters as well as relative bioavailability were calculated with 3p97 software and bioequivalence was analysed with NDST software RESULTS:The concentration-time curves of domestic clindamycin phosphate capsules or imported Dalacin C were well fitted for one-compartment open model The pharmacokinetic parameters of domestic and imported products wereTmax(0 94?0 51) and(0 75?0 35)h;Cmax(3 86?0 62)?g/ml and (4 08?0 60)?g/ml;AUC0～12(14 88?3 64)?g/(ml?h)and(16 07?3 68)?g/(ml?h)respectively There were no significant differences in AUC0～12 and Cmax between two products CONCLUSION:The relative bioavailability of clindamycin phosphate capsules was(93 4?14 9)% compared with imported Dalacin C The results showed that the two formulations were bioequivalent