STUDY ON PHARMACOKINETICS AND BIOEQUIVALENT EVALUATION OF FAMOTIDINE DISPERSIBLE TABLET

OBJECTIVE:The pharmacokinetics and relative bioavailability of two Famotidine preparations—dispersible tablet and reference tablet were studied. METHODS:Famotidine concentrations in 10 volunteers plasma were determined after a single oral dose of two famotidine preparations were given respectively to 10 volunteers in an open randomized cross over test. Famotidine concentrations in plasma were assayed by RP HPLC method. RESULTS: After taking a single oral dose of 40 mg two famotidine preparations,the AUC 0→∞ of famotidine dispersible tablet and tablet were (1075.37±226.07)ng·h·ml -1 and (1113.87±269.87)ng·h·ml -1 ; T max were (2.35±0.24)h and (2.45±0.16)h;C max were (186.13±48.34)ng·ml -1 and (164.74±35.00)ng·ml 1 respectively. CONCLUSION:The result of statistics analysis showed that there were no significant difference of the AUC 0→∞ 、T max and C max of famotidine between the two formations(P0.05) and the two famotidine preparations were bioequivalent