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KMID : 0369819990290010061
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Jorunal of Korean Pharmaceutical Sciences
1999 Volume.29 No. 1 p.61 ~ p.66
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Bioequivalence of Terasin Tablet to Hytrine Tablet ( Terazosin 2 mg )
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김수진/Kim SJ
임동구/신상철/박행순/오인준/문재동/이용복/Lim DK/Shin SC/Park HS/Oh IJ/Moon JD/Lee YB
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Abstract
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Bioequivalence of two terazosin tablets, the HytrineTM (Il-Yang Pharmaceutical Co., Ltd.) and the HytrineTM (Daewon Pharmaceutical Co., Ltd.), was evaluated according to the guideline of KFDA. Sixteen normal male volunteers (21∼30yearsold) were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 2 mg of terazosin was orally administered, blood was taken at predetermined time intervals and the concentration of terazosin in serum was determined with a HPLC method using spectrofluorometric detector. The pharmacokinetic parameters (AUCt,CmaxandTmax) were calculated and ANOVA was utilized for the statistical analysis of the parameters. The results showed that the differences in AUCt Cmax and Tmax between two tablets were 6.02%,3.44% and -3.67%, respectively. The powers (1?β) for AUCt, Cmax and Tmax were 98.05%, 98.34% and 29.81 %, respectively. Detectable differences (Δ) and confidence intervals were all less than ±20 except Tmax. AUCt and Cmax met the criteria of KFDA for bioequivalence, indicating that TerasinTM tablet is bioequivalent to HytrineTM tablet.
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KEYWORD
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Terazosin, HytrineTM, TerasinTM, Bioequivalence, HPLC
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