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Bioequivalence of two ondansetron, Zofran^(®) (Korea Graxowellcom Ltd.) and Gafron^(®) (Asia Pharm. Ind. Co.), was evaluated according to the guideline of KFDA. Sixteen healthy male volunteers (21-26 years old) were divided into two groups and a randomized 2×2 cross-over study was employed. After 8㎎ of ondansetron was orally administered, blood was taken at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours and just before administration. Plasma was analyzed for ondansetron and internal standard (loxapine) by a sensitive and validated HPLC assay. The pharmacokinetic parameters (AUCt, C_(max) and T_(max)) were calculated and ANOVA test was used for the statistical analysis of parameters. Differences in AUCt, C_(max) and T_(max) between two tablets were 2.87-3.17 and 0.00% respectively. All powers (1-β) for AUCt, C_(max) and T_(max) were more than 0.9. Detectable differences (Δ) and confidence interval were all less than ± 20%. All the parameters above met the criteria of KFDA for bioequivalence and indicated that Gafron^(®) Tablets are bioequivalent to Zofran^(®) Tablets.
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