Bioequivalence of Famotidine Chewing Tablets in Healthy Subjects
- VernacularTitle:法莫替丁咀嚼片的人体生物等效性研究
- Author:
Shiping WANG
- Publication Type:Journal Article
- Keywords:
famotidine;
chewing tablet;
pharmacokinetics;
bioequivalence
- From:
China Pharmacy
2001;0(08):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To compare the bioequivalence between famotidine chewing tablets and commercial tablets.ME THODS:A single dose of chewing or commercial tablets of famotidine was orally administered in a randomized crossover way in20volunteers and the plasma concentrations of famotidine were determined by HPLC.The pharmacokinetic parameters were calculated with3p97pharmacokinetic program and the bioequivalence was evaluated.RESULTS:The concentration-time curve of two preparations fitted two-compartment model.The peak plasma levels(C max )of chewing and commercial tablet of famotidine were(156.30?105.63)ng/ml and(156.83?99.62)ng/ml respectively.The peak time(T max )were(2.28?0.66)h and(2.28?0.77)h respectively.And AUC (0～24) were(857.55?517.39)and(912.94?638.17)(ng?h)/ml respectively.The relative bioavailability of chewing tablet of famotidine was(93.93?14.49)%.CONCLUSION:The results of two and one-side t tests suggest that the chewing tablet is bioequivalent to the commercial tablet of famotidine.
