|
Terbinafine has a primary fungicidal action mediated by squalene epoxidase inhibition. Treated fungi accumulate squalene while becoming deficient in ergosterol, an essential component of fungal cell membranes. Bioequivalence of two terbinafine tablets, Lamisil^{TM} (Novartis Korea Ltd., Seoul, Korea) and Mycosil^{TM} (Daewon Pharmaceutical Co., Ltd., Seoul, Korea), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen normal male volunteers (20sim29 years old) were randomly divided into two groups and a randomized 2times2 cross-over study was employed. After oral administration of Mycosil^{TM};or;Lamisil^{TM} (125 mg terbinafine), blood samples were taken at predetermined time intervals and the serum terbinafine concentrations were determined using an HPLC method with UV/VIS detector. The pharmacokinetic parameters (AUC_t,;C_{max};and;T_{max}) were calculated and ANOVA was utilized for the statistical analysis. The results showed that the differences in AUC_t,;C_{max};and;T_{max} between two tablets based on the Lamisil^{TM} tablet were -2.24%,;-7.68%;and;2.92%, respectively. The powers %(1-beta);for;AVC_t,;C_{max};and;T_{max};were;87.11%,;95.36%;and;99.99%, respectively. Minimum detectable differences (Delta);and;90% confidence intervals were all less than pm20%. All these parameters met the criteria of KFDA for bioequivalence, indicating that Mycosil^{TM} tablet is bioequivalent to Lamisil^{TM} tablet.
|