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지상철,이윤석,박은석 한국약제학회 1997 Journal of Pharmaceutical Investigation Vol.27 No.3
The bioequivalence of two nabumetone tablets was evaluated in 16 normal male volunteers (age 21∼30 yrs) 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 ㎎ 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, C_(max) and T_(max) were calculated and statistically analyzed for the bioequivalence of the two products. The results showed that the differences in AUC, C_(max) and T_(max) between two products were 3.66%, 6.87% and 1.85%, respectively. The powers(1-β) for AUC. C_(max) and T_(max) 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".