Pharmacokinetics and Bioequivalence Evaluation of 2 Cefadroxil Suspensions in Healthy Egyptian Male Volunteers.
The objective of this study was to evaluate the bioavailability of 2 brands of cefadroxil monohydrate suspensions, Curisafe (500 mg cefadroxil monohydrate/5 mL; test) relative to Duricef (500 mg cefadroxil monohydrate/5 mL; reference). This in vivo study was conducted according to a single-center, randomized, single-dose, laboratory-blinded, 2-period, 2-sequence, crossover design with a washout period of 1 week. Under fasting conditions, 24 healthy Egyptian adult male volunteers were randomly allocated to receive a single dose of either test or reference product. Blood samples were collected at specified time intervals, and plasma was analyzed for cefadroxil concentration using a validated high-performance liquid chromatography assay method. The pharmacokinetic parameters Cmax , AUC0-t , AUC0-∞ , tmax , Ke , and t1/2 were determined from plasma concentration-time profiles. The 90% confidence intervals for the ratio Cmax , AUC0-t , and AUCt-∞ of the test product over those of reference were within the acceptable range (0.8-1.25) for bioequivalence. On the basis of these results, the 2 cefadroxil formulations are considered bioequivalent.
Bioequivalence Unit, Faculty of Pharmacy, Tanta University, Tanta, Egypt.
Noha O
NO
Mansour
HPLC; bioequivalence; cefadroxil; pharmacokinetics