Bioequivalence Study of Famotidine Orally Disintegrating Tablet in Chinese Healthy Volunteers

OBJECTIVE To investigate the bioequivalence of famotidine orally distintegrating tablets (test formulation) and famotidine tablets (reference formulation) in Chinese healthy volunteers.METHODS A randomized,self-control,crossover design was adopted. The wash-out period was 7 d. 20 healthy male adult volunteers were administered famotidine 20 mg and blood samples were taken at 0,0.5,1,2,3,4,6,8,10,12 and 24 h. Plasma famotidine concentrations were assayed by solid-phase extraction and HPLC method.The pharmacokinetic parameters including AUC0-t,ρmax,tmax,t1/2 and CL/F were calculated by noncompartmental analysis.The bioequivalence of the two formulations was evaluated by analysis of variance and two one-sided t-test.RESULTS The HPLC method was sensitive,accurate and precise. The pharmacokinetic parameters of famotidine test and reference formulations were as follows:AUC0-t (480.3±144.8) and (470.9±164.7) μg·h·L-1,ρmax (83.1±26.9) and (87.2±35.3) μg·L-1,tmax (2.6±1.3) and (2.7±0.9) h,t1/2 (2.8±0.4) and (2.8±0.3) h,CL/F(42.1±13.2) and (43.5±13.4) L·h-1,respectively. The relative bioavailability of famotidine orally distintegrating tablets was 103.0% (90% CI:86.7%~115.3%). The statistical analysis showed that the two formulations were bioequivalent.CONCLUSION The famotidine orally distintegrating tablets are bioequivalent with famotidine tablets.