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리팜피신 제제인 리팜핀정의 리포덱스정에 대한 생물학적동등성
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  • 리팜피신 제제인 리팜핀정의 리포덱스정에 대한 생물학적동등성
저자명
한승훈,홍은경,안병진,채홍석,임동석,Han. Seung-Hoon,Hong. Eun-Kyung,Ahn. Byung-Jin,Chae. Hong-Seok,Yim. Dong-Seok
간행물명
臨床藥理學會誌= The journal of Korean Society for Clinical Pharmacology and Therapeutics
권/호정보
2007년|15권 2호|pp.99-106 (8 pages)
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대한임상약리학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

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).