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KMID : 0369819970270030207
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Jorunal of Korean Pharmaceutical Sciences
1997 Volume.27 No. 3 p.207 ~ p.212
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Bioequivalence of Nabumetone Tablets
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이윤석/Rhee YS
박은석/지상철/Park ES/Chi SC
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Abstract
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The bioequivalence of two nabumetone tablets was evaluated in 16 normal male volunteers (age21∼30yrs) following oral administration. Test product was 'Nacton tablet' made by Jin Yang Pharmaceutical Co. and reference product was 'Unimeton tablet' made by Dong Kwang Pharmaceutical Co.. After one tablet containing 500 mg of nabumetone was administered, blood was taken at predetermined time intervals and the concentration of 6-methoxy-2-naphthylacetic acid, active metabolite of nabumetone, in plasma was determined with an HPLC method using fluorescence detector. AUC, Cmax and Tmax were calculated and statistically analyzed for the bioequivalence of the two products. The results showed that the differences in AUC, Cmax and Tmax between two products were 3.66%, 6.87% and 1.85%, respectively. The powers(1?β) for AUC, Cmax and Tmax were 91.4%, 88.9% and 81.1%, respectively. Detectable differences(Δ) and confidence intervals were all less than 20%. All of these parameters met the criteria of FDA for bioequivalence, indicating that "Nacton tablet" is bioequivalent to 'Unimeton tablet'.
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KEYWORD
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Nabumetone tablet, Bioequivalence, Cmax, Tmax, HPLC
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