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KMID : 0941820000100010013
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Korean Journal of Clinical Pharmacy
2000 Volume.10 No. 1 p.13 ~ p.18
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Bioequivalence Evaluation of Pylocin Tablet to Klaricid Tablet (Clarithyomycin, 250 mg)
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조혜영
김수진/심영순/임동구/오인준/이용복/문재동
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Abstract
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The bioequivalence of two clarithromycin tablets, the Klaricid^{TM} (Ciba-Geigy Korea Ltd.) and the Pylocin^{TM} (Kyungdong Pharmaceutical Co., Ltd.), was evaluated according to the Korean Guidelines for Bioequivalence Test (KGBT 1998). Sixteen healthy male volunteers (20sim26 years old) were randomly divided into two groups and a randomized 2times2 cross-over study was employed. After one tablet containing 250 mg of clarithromycin was orally administered, blood sample was taken at predetermined time intervals, and the concentrations of clarithromycin in serum were determined using high-performance liquid chromatographic method with electrochemical detector. The pharmaco-kinetic parameters (area under the concentration-time curve: AUC_t, maximum concentration; C_{max} and time to maximum concentration; T_{max}) were calculated and analysis of variance (ANOVA) was utilized for the statistical analysis of parameters. The results showed that the differences in AUC_t,;C_{max};and;T_{max} between two tablets based on Klaricid^{TM} tablet were -0.22%,;-0.48%;and;-1.63%, respectively. The powers (1-beta);for;AUC_t,;C_{max};and;T_{max};were;99.07%,;88.15%;and;99.99%, respectively. Detectable differences (Delta);and;90% confidence intervals (alpha=0.10) were all less than pm20% All the parameters above met the criteria of KGBT 1998, indicating that Pylocin^{TM} tablet is bioequivalent to Klaricid^{TM} tablet.
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KEYWORD
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