Comparative bioavailability of two cefdinir suspension formulations in Middle Eastern healthy volunteers after single oral administration.

摘要

The aim of this study was to compare the bioavailability, after oral administration, of the generic "Adcef Suspension" (test) (125 mg/5 ml cefdinir; CAS 91832-40-5), with that of a commercially available original preparation (reference) (125 mg/ 5 ml cefdinir). For this purpose a randomized, two-way, crossover, bioequivalence study was performed in 24 healthy, male volunteers. The Middle Eastern selected volunteers were divided into two groups of 12 subjects. One group was treated with the reference standard and the other one with the test, with a crossover after the drug washout period of 7 days. Blood samples were collected at fixed time intervals and cefdinir concentrations were determined by a validated HPLC assay method. The pharmacokinetic parameters AUC(0-24), AUC(0-infinity), C(max), T(max), K(e) and T1/2 were determined for both formulations and were compared statistically to evaluate the bioequivalence betwee the two brands of cefdinir, using the statistical model recommended by the FDA. The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals (CI) fell within the acceptable range for bioequivalence. Based on the statistical evaluation it was concluded that the two formulations exhibit.