The pharmacokinetics and bioequivalance of famotidine tablets in healthy volunteers

Objective To study the pharmacokinetics and bioequivalence of famotidine in healthy volunteers.Methods Forty mg single oral dose of famotidine dispersible tablets and famotidine tablets were given to 10 healthy volunteers in an open randomized crossover. Famotidine concentrations in plasma were determined by HPLC method. The pharmacokinetic parameters as well as relative bioavailability were measured.Results The concentration time curves of famotidine were conformed to a one compartment model with a lag time. The main pharmacokinetic parameters of dispersible tablets and tablets famotidine were as follows: T max were (2.25± 0.42 )h and (2.40±0.57)h; C max were (163.29±37.93)μg/L and (162.46±17.91)μg/L; T 1/2K were (2.39± 0.31 )h and (2.50± 0.44 )h; AUC 0~12 were (705.97±202.27)μg·h·L 1 and (741.44±168.89)μg·h·L 1 respectively. There were no significant difference between the two formulations (P0.05). The relative bioavailability of famotidine dispersible tablet was 94%±10%.Conclusions The result of the statistical analysis showed that the two formulations were bioequivalent.