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라미실 정(테르비나핀 125 mg)에 대한 터비나 정의 생물학적 동등성
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  • 라미실 정(테르비나핀 125 mg)에 대한 터비나 정의 생물학적 동등성
저자명
김수진,정인성,조혜영,심영순,정태진,오인준,문재동,이용복,Kim. Soo-Jin,Jeong. In-Seong,Cho. Hea-Young,Shim. Young-Sun,Jeong. Tae-Jin,Oh. In-Joon,Moon. Jai
간행물명
藥劑學會誌
권/호정보
2000년|30권 2호|pp.133-138 (6 pages)
발행정보
한국약제학회
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정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

Terbinafine is an orally active antifungal agent as it inhibits the fungal enzyme squalene epoxidase, which is important in the early biosynthetic pathway of ergosterol. This leads to abnormal development of the fungal cell membrane. Bioequivalence of two terbinafine tablets, $Lamisil^{TM}$ (Novartis Korea Ltd.) and $Terbina^{TM}$ (Korean Drug Co., Ltd.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen normal male volunteers, $23.56{pm}1.75$ years old and $65.60{pm}8.54;kg$ of body weight, were divided into two groups and a randomized $2{ imes}2$ cross-over study was employed. After one tablet containing 125 mg of terbinafine was orally administered, blood was taken at predetermined time intervals and the serum concentrations of terbinafine were determined using an HPLC method with UV detector. The pharmacokinetic parameters $(AUC_t,;C_{max};and;T_{max})$ were calculated and ANOVA test was utilized for the statistical analysis of parameters. The results showed that the differences in $AUC_t,;C_{max};and;T_{max}$ between two tablets based on $Lamisil^{TM}$, tablet were -2.53%, -2.98% and 8.13%, respectively. The powers $(1-{eta})$ for $AUC_t,;C_{max};and;T_{max}$ were 85.21%, 98.21% and 93.11%, respectively. Minimum detectable differences $({Delta})$ at ${alpha}=0.1;and;1-{eta}=0.8$ were all less than 20%. The 90% confidence intervals were all within ${pm}20%$. All the parameters above met the criteria of KFDA for bioequivalence, indicating that $Terbina^{TM}$ tablet is bioequivalent to $Lamisil^{TM}$ tablet.