Pharmacokinetics and Bioavailability of Two Kinds of Famotidine Capsule in Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE:To study the pharmacokinetics of two kinds of famotidine capsule from different factories in healthy volunteers and to evaluate the bioavailability of them METHODS:A single oral 40 mg dose of famotidine capsule of reference or test preparation was given to healthy male volunteers according to an open randomized crossover study The plasma concentrations of famotidine were determined by a RP-HPLC method The pharmacokinetic parameters and bioavailability of test preparation were compared with reference preparation RESULTS:The main pharmacokinetic parameters of the reference preparation and the test preparation were as followsCmax were(189 9?72 1)?g/L and(170 1?59 6)?g/L;Tmax were(2 5?0 8)h and (2 1?0 8)h;T1/2 were(4 1?0 9)h and(3 8?0 8)h;AUC0～t were (1 031 7?316 7)?g/(L?h)and(1 019 4?290 5)?g/(L?h);AUC0→∞ were(1 123 9?346 0)?g/(L?h)and(1 103 4?312 0)?g/(L?h);The relative bioavailability of reference to test preparation was(101 6?22 6)% CONCLUSION:The results showed that the reference preparation and the test preparation were bioequivalent