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KMID : 0369820100400020125
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Jorunal of Korean Pharmaceutical Sciences
2010 Volume.40 No. 2 p.125 ~ p.131
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Bioequivalence of LANIDIEM(R)
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Lee Yun-Young
Kim Hye-Jin
Na Soo-Kie
Cho Kyung-Hee
Jang Moon-Sun
Park Young-Joon
Lee Hee-Joo
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Abstract
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A bioequivalence study of LANIDIEM tablet 4 mg (Samil. Co., Ltd.) to Vaxar 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 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. (the area under the plasma concentration-time curve from time zero to 24 hr) was calculated by the linear trapezoidal rule method. (maximum plasma drug concentration) and (time to reach ) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed and . 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 ratio and the ratio for LANIDIEM/Vaxar 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 tablet 4 mg and Vaxar tablet 4 mg with respect to the rate and extent of absorption.
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KEYWORD
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Lacidipine, LANIDIEM tablet, Vaxar tablet, Bioequivalence, LC-MS/MS
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