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KMID : 0616620040100010085
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Journal of Soonchunhyang Medical College
2004 Volume.10 No. 1 p.85 ~ p.88
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Bioequivalence study of a generic simvastatin tablet preparation
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Kim Hyung-Kee
Kwon Jun-Tack
Sohn Dong-Ryul
Yom Yoon-Ki
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Abstract
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The bioequivalence of generic simvastatin tablet(Dongsung Pharmaceutical Co.) to the simvastatin tablet(Zocor®, MSD Korea Co.) as a reference drug. Single dose of 20 mg simvastatin was administered to 20 healthy male volunteers in a balanced, randomized crossover design with a washout between the two study periods. Blood samples were collected up to 12 hours and plasma concentration of simvastatin was measured by well validated LC-MS/MS. Pharmacokinetic parameters were analyzed by non-compartmental analysis and ANOVA test was used for the statistical analysis of parameters. No statistically significant formulation, period, or sequence effect was encountered. Ninety percent confidence intervals of log transformed C_(max) and AUC_(t) were comprised in the stipulated 0.80-1.25 range. These results suggest that test formulation of simvastatin is bioequivalent with the reference, both formulations in 20 mg tablet.
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KEYWORD
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bioequivalence, bioavailability, simvastatin, LC-MS/MS
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