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KMID : 0616620040100010077
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Journal of Soonchunhyang Medical College
2004 Volume.10 No. 1 p.77 ~ p.80
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Bioequivalence Study of a Generic Cefixime Capsule 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 cefixime(Pofixim®, Kwangmyung Pharmaceutical Co.) capsule to the cefixime capsule(Suprax®, Dong-A Pharmaceutical Co.) as a reference drug. Single dose of 100 mg cefixime 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 14 hours and plasma concentration of cefixime was measured by well validated reverse phase high-performance liquid chromatography. 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 cefixime can be declared bioequivalent with the reference, both formulations in 100 mg capsule.
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KEYWORD
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bioequivalence, bioavailability, cefixime, Pofixim®, Suprax®
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