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KMID : 0941820040140020085
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Korean Journal of Clinical Pharmacy
2004 Volume.14 No. 2 p.85 ~ p.90
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Bioequivalence of Bisoprolol Tablet (Bisoprolol hemifumarate 5 mg)
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Ko In-Ja
Chi Sang-Cheol
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Abstract
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Bisoprolol, one of the beta_1-adrenorecepter antagonist, has been used for the treatment of mild to moderate essential hypertension anti stable angina pectoris. The oral bloavailability of bisoprolo1 is high (90%) and the drug has a long elimination half-life, 9{sim}12;hr, which allows once-daily administration. The bioequivalence of two bisoprolol preparations was evaluated according to the guidelines of Korea Food & Drug Administration (KFDA). The test product was Concor tablet^{(R)} made by Newgenpharm and the reference product was Monocor tablet^{(R)} made by Wyeth Korea. Twenty healthy male subjects, 23.8 (21-30) years old and 03.8(52-92) kg, were randomly divided into two groups and a randomized 2times2 cross-over study was employed. After two tablets containing 10 mg bisoprolol hemifumarate were orally administered, blood was taken at predetermined time intervals and the concentration of bisoprolol in plasma was determined using an HPLC method with fluorescence detector. Two pharmacokinetic parameters, AUC_t;and;C_{max} were calculated and analyzed statistical]y for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The 90% confidence intervals of AUC_t;and;C_{max} were log 0.95{sim}1og;1.04;and;1og;0.96{sim}1og;1.07,;respectively. These values were within the acceptable bioequivalence intervals of log 0.8{sim}log;1.23. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Concor tablet is bioequivalent to Monocor tablet.
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KEYWORD
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Bisoprolol, Bioequlvalence, HPLC
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