Comparative bioavailability of two different tablets of famotidine in twenty four healthy volunteers

Abstract

Objective: A comparative bioavailability study was established on two 40 mg tablets of famotidine (test product: Famodin 40 mg Ilsan Ilaclari A.S., Turkey; reference product: Pepdine 40 mg, Merck, Sharp and Dohme, France) after the application of a single oral dose to twenty four healthy volunteers. Methods: A two-way crossover randomized study applied to 12 female and 12 male subjects with a one-week wash-out period between two formulations. Blood samples were collected prior to (time zero) and at 14 time points within 24 hrs after dosing. Plasma concentrations of famotidine were determined via high performance liquid chromatographic method in France by CEPHAC Bioanalytical Research Center. Results: Absorption and disposition of famotidine after a single oral administration of 40 mg are comparable between the two formulations. C(max) values were determined as 174 ± 59 ng/ml and 151 ± 49 ng/ml (90% confidence intervals 1.00-1.32), and AUC(0-∞) values were 947 ± 273 ng.ml-1.h and 868 ± 265 ng.ml-1.h (90% confidence intervals 0.99-1.21) for the test and the reference formulations, respectively. Conclusion: The study has shown that the two formulations are bioequivalent with respect to the rate and extent of absorption of famotidine after a single oral administration of 40 mg famotidine in healthy volunteers.