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KMID : 0369820000300030213
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Jorunal of Korean Pharmaceutical Sciences
2000 Volume.30 No. 3 p.213 ~ p.218
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Bioequivalence of Hana Ondansetron Tablet to Zofran Tablet ( Ondansetron 8 mg )
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조혜영/Cho HY
김수진/심영순/임동구/오인준/문재동/이용복/Kim SJ/Shim YS/Lim DK/Oh IJ/Moon JD/Lee YB
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Abstract
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Ondansetron is a potent, highly selective 5-hydroxytryptamine3(5-HT3) receptor- antagonist, for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiography, and the treatment of post-operative nausea and vomiting. The purpose of the present study was to evaluate the bioequivalence of two ondansetron tablets, ZofranTM, (Glaxo Wellcome Korea Ltd.) and Hana ondansetron (Hana Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, 23.56±1.79 year in age and 67.35±8.35kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 8 mg of ondansetron was orally administered, blood was taken at predetermined time intervals and the concentrations of ondansetron in serum were determined using HPLC with UV detector. Pharmacokinetic parameters such as AUCt,CmaxandTmax were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in AUCt,CmaxandTmax between two tablets were 7.53%, -0.23% and -3.92%, respectively when calculated against the ZofranTM, tablet. The powers (1?β) for AUCt,CmaxandTmax were above 99.00%, above 99.00% and 84.99%, respectively. Minimum detectable differences (Δ)atα=0.1and1?β=0.8 were all less than 20% (e.g., 12.25%, 10.88% and 18.37% for AUCt,CmaxandTmax, respectively). The 90% confidence intervals were all within ±20 (e.g., ?0.70∼15.76,?7.53∼7.08and?16.27∼8.42forAUCt,CmaxandTmax, respectively). All of the above parameters met the criteria of KFDA for bioequivalence, indicating that Hana ondansetron tablet is bioequivalent to ZofranTM, tablet.
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KEYWORD
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Ondansetron, ZofranTM, Hana ondansetron, Bioequivalence, HPLC
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