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      정상성인에서 Gliclazide 정제의 생물학적동등성에 관한 연구

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      https://www.riss.kr/link?id=A82333250

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      다국어 초록 (Multilingual Abstract)

      The bioequivalence of generic gliclazide tablet(Shinil Pharmaceutical Co.) to the gliclazide tablet(Diamicron®,
      Beohringer Ingelheim Korea Co.) as a reference drug. Single dose of 80 mg gliclazide was administered to
      24 healthy male volunteers in a balanced, randomized crossover design. Blood samples were collected
      serially up to 24 hours and plasma concentration of gliclazide was measured by well validated HPLC.
      Pharmacokinetic parameters were analyzed by non-compartmental analysis and ANOVA test was used for the
      statistical analysis of parameters. No statistically significant formulation, period, or sequence effect was
      encountered. Ninety percent confidence intervals of log transformed Cmax and AUCt were comprised in the
      stipulated 0.80-1.25 range. These results suggest that tested generic product of gliclazide is bioequivalent to
      the reference drug, both formulations in 80 mg tablet.
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      The bioequivalence of generic gliclazide tablet(Shinil Pharmaceutical Co.) to the gliclazide tablet(Diamicron®, Beohringer Ingelheim Korea Co.) as a reference drug. Single dose of 80 mg gliclazide was administered to 24 healthy male volunteers in a b...

      The bioequivalence of generic gliclazide tablet(Shinil Pharmaceutical Co.) to the gliclazide tablet(Diamicron®,
      Beohringer Ingelheim Korea Co.) as a reference drug. Single dose of 80 mg gliclazide was administered to
      24 healthy male volunteers in a balanced, randomized crossover design. Blood samples were collected
      serially up to 24 hours and plasma concentration of gliclazide was measured by well validated HPLC.
      Pharmacokinetic parameters were analyzed by non-compartmental analysis and ANOVA test was used for the
      statistical analysis of parameters. No statistically significant formulation, period, or sequence effect was
      encountered. Ninety percent confidence intervals of log transformed Cmax and AUCt were comprised in the
      stipulated 0.80-1.25 range. These results suggest that tested generic product of gliclazide is bioequivalent to
      the reference drug, both formulations in 80 mg tablet.

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