Cefixime 경구제제의 생물학적 동등성 연구 = Bioequivalence Study of a Generic Cefixime Capsule Preparation

다국어 초록 (Multilingual Abstract)

The bioequivalence of generic cefixime(Pofixim^(®), Kwangmyung Pharmaceutical Co.) capsule to the cefixime capsule(Suprax^(®), Dong-A Pharmaceutical Co.) as a reference drug. Single dose of 100 mg cefixime was administered to 20 healthy male volunteers in a balanced, randomized crossover design with a washout between the two study periods. Blood samples were collected up to 14 hours and plasma concentration of cefixime was measured by well validated reverse phase high-performance liquid chromatography. Pharmacokinetic parameters were analyzed by non-compartmental analysis and ANOVA test was used for the statistical analysis of parameters. No statistically significant formulation, period, or sequence effect was encountered. Ninety percent confidence intervals of log transformed C_(max) and AUC_(t) were comprised in the stipulated 0.80-1.25 range. These results suggest that test formulation of cefixime can be declared bioequivalent with the reference, both formulations in 100 mg capsule.