Study on Bioequivalence of Amoxicillin and Dicloxacillin Sodium Dispersible Tablets in Human Body

OBJECTIVE: To study the relative bioequivalence of Amoxicillin and Dicloxacillin Sodium dispersible tablets in human body.METHODS: The plasma concentrations of amoxicillin and dicloxacillin in 20 healthy male volunteers were determined by HPLC method after being orally administered with single dose of 750mg test and reference preparation by randomized crossover way;the pharmacokinetic parameters and the relative bioequivalence of the two preparations of amoxicillin and dicloxacillin were calculated by DAS software.RESULTS: The main pharmacokinetic parameters of amoxicillin were as follows: tmax were(1.16± 0.26) and (1.24± 0.27) h,Cmax were(6.32± 2.56) and(6.59± 2.33) μ g· mL-1,AUC0～ 7 were(12.27± 2.25) and(12.66± 2.68) μ g· h· mL-1,AUC0～ ∞ were(15.48± 2.38) and(15.47± 3.71) μ g· h· mL-1.Pharmacokinetic parameters of dicloxacillin were as follows: tmax were(0.94± 0.23) and(0.93± 0.18) h,Cmax were(12.12± 5.71) and(12.12± 4.15) μ g· mL-1,AUC0～ 7 were(23.49± 4.20) and(23.25± 3.64) μ g· h· mL-1,AUC0～ ∞ were(24.93± 3.96) and(24.50± 3.66) μ g· h· mL-1.The relative bioavailability of amoxicillin were(97.7± 8.2) % and(102.0± 16.8) % for dicloxacillin.CONCLUSION: Amoxicillin and Dicloxacillin Sodium dispersible tablets and capsules were bioequivalent.