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Candidate SCOPUS
단보 / 라미실 정 ( 테르비나핀 125 mg ) 에 대한 터비나 정의 생물학적 동등성
Bioequivalence of Terbina Tablet to Lamisil Tablet ( Terbinafine 125 mg )
김수진(Soo Jin Kim),정인성(In Seong Jeong),조혜영(Hea Young Cho),심영순(Young Sun Shim),정태진(Tae Jin Jeong),오인준(In Joon Oh),문재동(Jai Dong Moon),이용복(Yong Bok Lee)
UCI I410-ECN-0102-2009-510-006668674

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±1.75 years old and 65.60±8.54㎏ of body weight, were divided into two groups and a randomized 2 × 2 cross-over study was employed. After one tablet containing 125 ㎎ 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-β) for AUC_t, C_(max) and T_(max) were 85.21%, 98.21% and 93.11%, respectively. Minimum detectable differences (△) at α=0.1 and 1-β=0.8 were all less than 20%. The 90% confidence intervals were all within ±20%. All the parameters above met the criteria of KFDA for bioequivalence, indicating that Terbina^(TM) tablet is bioequivalent to Lamisil^(TM) tablet.

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