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박사르?정 4 밀리그램(라시디핀 4 mg)에 대한 라니디엠?정 4 밀리그램의 생물학적동등성
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  • 박사르?정 4 밀리그램(라시디핀 4 mg)에 대한 라니디엠?정 4 밀리그램의 생물학적동등성
저자명
이윤영,김혜진,나숙희,조경희,장문선,박영준,이희주,Lee. Yun-Young,Kim. Hye-Jin,La. Sookie,Cho. Kyung-Hee,Jang. Moon-Sun,Park. Young-Joon,Lee. Hee-Joo
간행물명
藥劑學會誌
권/호정보
2010년|40권 2호|pp.125-131 (7 pages)
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한국약제학회
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정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

A bioequivalence study of LANIDIEM$^{(R)}$ tablet 4 mg (Samil. Co., Ltd.) to Vaxar$^{(R)}$ tablet 4 mg (GlaxoSmithKline Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Forty healthy male Korean volunteers were enrolled in the study and thirty six volunteers completed the study according to the protocol. Thirty six volunteers received each medicine at the lacidipine dose of 4 mg in a $2{ imes}2$ crossover study. There was one week wash-out period between the doses. Plasma concentrations of lacidipine were monitored by a high performance liquid chromatography - tandem mass spectrometry (LC-MS/MS) for over a period of 24 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 24 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for LANIDIEM$^{(R)}$/Vaxar$^{(R)}$ were log 0.8102~log 1.0417 and log 0.8493~log 1.1439, respectively. These values were within the acceptable bioequivalence intervals of log 0.80~log 1.25. Thus, our study demonstrated the bioequivalence of LANIDIEM$^{(R)}$ tablet 4 mg and Vaxar$^{(R)}$ tablet 4 mg with respect to the rate and extent of absorption.