Archives of Pharmacal Research

  • 제18권5호
  • /
  • Pages.340-345
  • /
  • 1995
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  • 0253-6269(pISSN)
  • /
  • 1976-3786(eISSN)
대한약학회 (The Pharmaceutical Society of Korea)
권호 표지

Bioeuqivalence Study of Nabumetone Tablets in Man

  • Lee, Young-Joo (Department of Pharmaceutics, College of Pharmacy, Seoul National University) ;
  • Jang, Eun-Ju (Department of Pharmaceutics, College of Pharmacy, Seoul National University) ;
  • Lee, Jeong-Uk (Department of Pharmaceutics, College of Pharmacy, Seoul National University) ;
  • Han, Yong-Hae (Department of Pharmaceutics, College of Pharmacy, Seoul National University) ;
  • Chung, Suk-Jae (Department of Pharmaceutics, College of Pharmacy, Seoul National University) ;
  • Lee, Min-Hwa (Department of Pharmaceutics, College of Pharmacy, Seoul National University) ;
  • Shim, Chang-Koo (Department of Pharmaceutics, College of Pharmacy, Seoul National University)
  • 발행 : 1995.10.01
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초록

A nebumetone tablet in development $(Navuton^R)$ was tested for its bioequivalence to the erference tablet $(Uniton^R)$. 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 $(C_{max})$ and time to reach the maximum concentration$(T_{max})$ 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 $C_{max}$ and $T_{max}$ were read from the highest serum peaks. calculated bioavailability parameters for test and reference tablets were 148.6 : 1377.9 $\mug \cdot hr/ml$ for AUC; 25.2:23.1 $\mu/ml$ for $C_{max}$; 11.8:16.4 hr for $T_{max}$, 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 ($C_{max}$ and $T_{max}$, 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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