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KMID : 0369820000300020133
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Jorunal of Korean Pharmaceutical Sciences
2000 Volume.30 No. 2 p.133 ~ p.138
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Bioequivalence of Terbina Tablet to Lamisil Tablet ( Terbinafine 125 mg )
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김수진/Kim SJ
정인성/조혜영/심영순/정태진/오인준/문재동/이용복/Jeong IS/Cho HY/Shim YS/Jeong TJ/Oh IJ/Moon JD/Lee YB
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Abstract
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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, LamisilTM (Novartis Korea Ltd.) and TerbinaTM (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±8.54kg of body weight, were divided into two groups and a randomized 2×2 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 (AUCt,CmaxandTmax) were calculated and ANOVA test was utilized for the statistical analysis of parameters. The results showed that the differences in AUCt,CmaxandTmax between two tablets based on LamisilTM, tablet were -2.53%, -2.98% and 8.13%, respectively. The powers (1?β) for AUCt,CmaxandTmax were 85.21%, 98.21% and 93.11%, respectively. Minimum detectable differences (Δ) at α=0.1and1?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 TerbinaTM tablet is bioequivalent to LamisilTM tablet.
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KEYWORD
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Terbinafine, LamisilTM, TerbinaTM, Bioequivalence, HPLC
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