Bioequivalence Study of Famotidine Orally Disintegrating Tablet in Chinese Healthy Volunteers
DU Xiao-li，FU Qiang，YE Min，ZHU Zhu，LI Da-kui
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Department of Pharmacy，Peking Union Medical College Hospital，Chinese Academy of Medical Sciences and Peking Union Medical College，Beijing 100730，China
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Received
Published
2006-07-03
2007-04-10
Issue Date
2007-04-10
Abstract
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.
DU Xio-li;FU Qing;YE Min;ZHU Zhu;LI D-kui.
Bioequivalence Study of Famotidine Orally Disintegrating Tablet in Chinese Healthy Volunteers [J]. Chinese Pharmaceutical Journal, 2007, 42(08): 609-612
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