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KMID : 0043319950180050340
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Archives of Pharmacal Research
1995 Volume.18 No. 5 p.340 ~ p.345
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Bioeuqivalence Study of Nabumetone Tablets in Man
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Lee Young-Joo
Jang Eun-Ju
Lee Jeong-Uk
Han Yong-Hae
Chung Suk-Jae
Lee Min-Hwa
Shim Chang-Koo
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Abstract
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A nebumetone tablet in development was tested for its bioequivalence to the erference tablet . Seventeen healthy Korean male subjects participated in this study. Each subject received a 1-g dose of nabumetone (2tables each) in an unbalanced, randomized, two-way crossover investigation. Serum concentrations of 6-methoxy-2-na-phthylacetic acid (6-MNA), a major metabolite of nebumetone, were measured over 120 hr interval by a high-performance liquid chromatography. The maximum serum concentration and time to reach the maximum concentration were read directly, but area under the serum concentration time curve from time 0 to 120 hr (AUC) and mean residence time serum curves showed multiple peaks of 6-MNA in most subjects, and the and were read from the highest serum peaks. calculated bioavailability parameters for test and reference tablets were 148.6 : 1377.9 for AUC; 25.2:23.1 for ; 11.8:16.4 hr for , and 42.6 : 43.8 hr for MRT, respectively. The paired t-test revealed no significant differences in all the parameters between the two tablets. Analysis ofl variance (ANOVA) revealed no significant differences between groups and formulations in all the parameters ( and , AUC and MRT) indicating the crossover design of the experiment was properly performed. But significant differences (p<0.05) between subject/groups and periods were found for all the parameters indicating substantial intersubject and interperiodic variations for these parameters.
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KEYWORD
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Nabumetone, 6-Methoxy-2-naphthylacetic acid(6-MNA), Bioquivalence, AUC, $C_{max}{\, }T_{max}$, MRT, Multiple peaks, ANOVA
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