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라미실 정(테르비나핀 125 mg)에 대한 미코실 정의 생물학적 동등성
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  • 라미실 정(테르비나핀 125 mg)에 대한 미코실 정의 생물학적 동등성
저자명
조혜영,박현진,정경희,조행남,문재동,이용복,Cho. Hea Young,Park. Hyun Jin,Jeong. Kyung Hee,Cho. Haeng Nam,Moon. Jai Dong,Lee. Yong Bok
간행물명
한국임상약학회지
권/호정보
2000년|10권 2호|pp.62-67 (6 pages)
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한국임상약학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

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 $2 imes2$ 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-eta);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.