|
Bioequivalence of two flouxetine capsule, Prozac^(®) (Lilly korea Ltd.) and Lanclic^(®) (Samsung Pharm. IND. Co.), was evaluated according to the guideline of KFDA. Twenty four healthy male volunteers (21-26 years old) were divided into two groups and a randomized 2×2 cross-over study was employed. After 60㎎ of fluoxetine was orally administered, blood was taken at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 32, 48 and 72 hours after administration and just before administration. Plasma was analyzed for fluoxetine and internal standard (clomipramine) by a sensitive and validated HPLC assay. The pharmacokinetic parameters (AUC_(t), C_(max) and T_(max)) were calculated and ANOVA test was used for the statistical analysis of parameters. Differences in AUC_(t), C_(max) and T_(max) between two capsules were -0.90, 3.46 and -14.08% respectively. All powers (1-β) for AUC_(t), 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 Lanclic^(®) capsules are bioequivalent to Prozac^(®) capsules.
|