리팜피신 제제인 리팜핀정의 리포덱스정에 대한 생물학적동등성

Bioequivalence study of $Rifampin^{(R)}$ Tablet to $Rifodex^{(R)}$ Tablet(Rifampicin 600mg)

Background: Rifampicin is commonly used antimycobacterial drug and various formulations are available. The purpose of this study is to evaluate the bioequivalence of rifampicin in healthy Korean subjects. Methods: Under two way crossover Latin square design (2 sequences, 2 periods), twenty-one subjects were randomly allocated into two groups. After administration of rifampicin 600mg, blood sampling was done at prescheduled time points. Samples were analyzed using HPLC/UV method. Using WinNonlin V5.2, $C_{max},\;AUC_t$ and $T_{max}$ were calculated. ANOVA test was done for each pharmacokinetic parameter after log transformation. Results: There was no significant difference between 2 groups in demographic profile. Average AUCt of $Rifodex^{(R)}$ was $101.947{\pm}38.763\;ug{\cdot}hr/ml\;(Mean{\pm}SD)$ and that of $Rifampin^{(R)}$ was $104.480{\pm}38.122\;ug{\cdot}hr/ml\;(Mean{\pm}SD)$. Average $C_{max}$ was $16.399{\pm}5.367\;ug/ml\;(Mean{\pm}SD)$ for $Rifodex^{(R)}$, and $16.442{\pm}6.013\;ug/ml\;(Mean{\pm}SD)$ for $Rifampin^{(R)}$. Bioequivalence test for log($AUC_t$) and log($C_{max}$) showed that the 90% confidence interval for difference between 2 formulation is $-0.1128{\sim}0.0061,\;-0.0893{\sim}0.0779$. These values were within the bioequivalence range of -0.2231(=log 0.8)$\sim$0.2231(=log 1.25). Conclusion: Our study revealed that $Rifampin^{(R)}$ is bioequivalent to $Rifodex^{(R)}$ according to the guideline of Korea Food and Drug Administration(KFDA).