원문정보
초록
영어
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, (Novartis Korea Ltd., Seoul, Korea) and (Daewon Pharmaceutical Co., Ltd., Seoul, Korea), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen normal male volunteers ( years old) were randomly divided into two groups and a randomized cross-over study was employed. After oral administration of (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 were calculated and ANOVA was utilized for the statistical analysis. The results showed that the differences in between two tablets based on the tablet were , respectively. The powers , respectively. Minimum detectable differences confidence intervals were all less than . All these parameters met the criteria of KFDA for bioequivalence, indicating that tablet is bioequivalent to tablet.