Bioequivalence Study of Two Cephalexin Formulations, $Kepacin^{TM}$ Capsule and $Falexin^{TM}$ Capsule

세팔렉신 제제인 케파신캡슐$^{TM}$의 팔렉신캡슐$^{TM}$에 대한 생물학적동등성

Backgound: Cephalexin is one of the first generation cephalosporins that has antibactericidal activity against gram-positive microorganisms. The purpose of the present study is to evaluate the bioequivalence of two cephalexin formulations(Kepacin capsule 500mg vs Falexin capsule 500mg), according to the guideline of the Korea Food and Drug Administration (KFDA) Methods: Twenty three healthy Korean male volunteers participated in this study. Under two-way, crossover, Latin-square design (1-week wash-out period), a pharmacokinetic study and bioequivalence test was performed. After oral administration of cephalexin 500mg, blood samples were taken at predetermined time points and the concentrations of cephalexin were quantified using HPLC/UV method. WinNonlin V5.0 was utilized for calculation of the pharmacokinetic parameters including $AUC_t,\;C_{max}$. Results: There were no significant differences in demographic and pharmacokinetic characteristics between $Kepacin^{TM}\;and\;Falexin^{TM}$. ANOVA test found no significant sequence effects for $AUC_t\;and\;C_{max}$. The 90% confidence intervals of the mean difference of log($AUC_t\;and\;C_{max}$) for $Kepacin^{TM}$ versus $Falexin^{TM}$ were log 0.94$\sim$log 1.03 and log 0.92$\sim$log 1.18, respectively. These values were within the bioequivalence range of log 0.8$\sim$log 1.25. Conclusion: Our study indicated that the pharmacokinetic profiles of cephalexin in Korean male subjects were not different from previous reports except low clearance. $Kepacin^{TM}$ was bioequivalent to $Falexin^{TM}$ with respect to the extent and rate of absorption.