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Bioequivalence of two lovastatin tables, Mevacor (Choongwae Pharma Corporation) and Bairotin (Samsung 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 80㎎ of lovastatin was orally administrated, blood was taken at 1, 2, 2.5, 3, 3.5, 4, 6, 8, 10 and 12 hours after administration and just before administration. Lovastatin is rapidly metabolized to β-hydroxy acid form that is pharmacologically active. So the concentrations of its β-hydroxy acid form were determined by HPLC method with UV detection. The pharmacokinetic parameters(AUCt, Cmax and Tmax,) were calculated and ANOVA test was used for the statistical analysis of parameters. Differences in ACUt, Cmax and Tmax between two tables were 0.47, 3.13 and 5.75% respectively. All powers(1-β) for AUCt, Cmax and Tmax 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 Bairotin^(®) tables are bioequivalent to Mevacor^(®) tablets.
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