COMPARATIVE BIOAVAILABILITY OF TWO DIFFERENT TABLETS OF FAMOTIDINE IN TWENTY FOUR HEALTHY VOLUNTEERS

Authors : Ece İSKENDER, Serhan TUĞLULAR, Zafer GÖREN, Rezzan Aker, Ahmet Akıcı, Atila Karaalp, Neslihan Aslan, Mehmet Koç, Filiz Onat, Emel Akoğlu, Kemal Berkman, Şule Oktay

Pages : 74-78

View : 15 | Download : 9

Publication Date : 2016-12-03

Article Type : Research Paper

Abstract :Objective: A comparative bioavailability study was established on two 40 mg tablets of famotidine insert ignore into journalissuearticles values(test product: Famodin 40 mg ilsan ilaçları A.Ş., Turkey; reference product: Pepdine 40mg, Merck, Sharp & 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 insert ignore into journalissuearticles values(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 CEPFIAC Bioanalytical Research Center. Results: Absorption and disposition of famotidine after a single oral administration of 40 mg are comparable between the two formulations. Cmax values were determined as 174 ± 59 ng/ml and 151 ±49 ng/ml insert ignore into journalissuearticles values(90% confidence intervals 1.00-1.32);, and AUCq.^ values were 947 ± 273 ng.ml`1.h and 868 ± 265 ng.ml`1.h insert ignore into journalissuearticles values(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. Key Words: Famotidine, Bioavailability, Bioequivalence.
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