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KMID : 0391020070150020099
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Journal of Korean Society for Clinical Pharmacology and Therapeutics
2007 Volume.15 No. 2 p.99 ~ p.106
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Bioequivalence study of Rifampin Tablet to Rifodex Tablet(Rifampicin 600mg)
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Han Seung-Hoon
Yim Dong-Seok
Hong Eun-Kyung
Ahn Byung-Jin
Chae Hong-Seok
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Abstract
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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, and 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 was and that of was . Average was for , and for . Bioequivalence test for log() and log() showed that the 90% confidence interval for difference between 2 formulation is . These values were within the bioequivalence range of -0.2231(=log 0.8)0.2231(=log 1.25).
Conclusion: Our study revealed that is bioequivalent to according to the guideline of Korea Food and Drug Administration(KFDA).
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KEYWORD
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Bioequivalence, Rifampin, Rifodex
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