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논문 기본 정보
- 자료유형
- 학술대회자료
- 저자정보
- 발행연도
- 1997.1
- 수록면
- 117 - 117 (1page)
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초록· 키워드
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Sandimmune Neoral$\^$(R)/ and Neoplanta$\^$(R)/ capsules were administered to twenty four healthy Korean male subjects at a cyclosporin A (CsA) dose of 175 mg in a 2 ${\times}$ 2 crossover investigation with a two-week wash-out phase. Concentrations of CsA in blood were measured by RIA method for over a period of 48 h. Result : The two formulations were found bioequivalent, but analysis of variance (ANOVA) indicated that there is a significant (p<0.01) period effect in AUC$\_$0-LAST/ (area under the blood concentration above assay limit of quantification-time curve) and C$\_$MAX/ (maximum blood concentration) between the administrations. Paired t-test revealed 6 and 9% decreases in AUC$\_$0-LAST/ and C$\_$MAX/, respectively at the second administration. This period effect on the pharmacokinetics of CsA may be relevant for the patients who need consecutive administration of the drug. A number of mechanisms, such as induction of the enzymes responsible for metabolism of the drug in the gut wall and/or liver and modulation of P-glycoprotein upon the consecutive dosing, appear consistent with the change, and needs experimental proof.
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