Study on Pharmacokinetics and Bioequivalence of Two Products of Cefadroxil Capsules in Healthy Volunteers
- VernacularTitle:两种头孢羟氨苄胶囊的药代动力学与生物等效性研究
- Author:
Ling MENG
;
Jing ZHANG
;
Zhigao SHAO
- Publication Type:Journal Article
- Keywords:
cefadroxil;
HPLC;
pharmacokinetics;
bioequivalence
- From:
China Pharmacy
2001;0(12):-
- CountryChina
- Language:Chinese
-
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 follows:T1/2ke 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
