Bioequivalence of Famotidine Chewing Tablets in Healthy Subjects

OBJECTIVE:To compare the bioequivalence between famotidine chewing tablets and commercial tablets.ME THODS:A single dose of chewing or commercial tablets of famotidine was orally administered in a randomized crossover way in20volunteers and the plasma concentrations of famotidine were determined by HPLC.The pharmacokinetic parameters were calculated with3p97pharmacokinetic program and the bioequivalence was evaluated.RESULTS:The concentration-time curve of two preparations fitted two-compartment model.The peak plasma levels(C max )of chewing and commercial tablet of famotidine were(156.30±105.63)ng/ml and(156.83±99.62)ng/ml respectively.The peak time(T max )were(2.28±0.66)h and(2.28±0.77)h respectively.And AUC (0～24) were(857.55±517.39)and(912.94±638.17)(ng·h)/ml respectively.The relative bioavailability of chewing tablet of famotidine was(93.93±14.49)%.CONCLUSION:The results of two and one-side t tests suggest that the chewing tablet is bioequivalent to the commercial tablet of famotidine.