Study on Pharmacokinetics and Bioequivalence of Two Products of Cefadroxil Capsules in Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE:To study the bioequivalence between cefadroxil capsules and its reference capsules and pharmacokinetics in 22 male healthy volunteers METHODS:A dose of 1 000mg cefadroxil(test and reference products)was given according to a randomized cross-over design Plasma concentrations of cefadroxil and internal standard(amoxicillin) were determined by HPLC RESULTS:The concentration-time curves of both preparations fitted to a one-compartment model The main parameters of test and reference products were as followsT1/2ke were (1 40?0 15)h and (1 44?0 23)h;Tmax were (2 3?0 5)h and (2 2?0 3)h;peak concentrations(Cmax) were (30 59?4 25)?g/ml and(30 57?4 24)?g/ml,AUC were(99 31?14 50)?g/(ml?h) and (99 22?15 11)?g/(ml?h)respectively CONCLUSION:Relative bioavailability was(100 42?7 62)% The two formulations were bioequivalent