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탈리플루메이트 제제에 대한 생물학적동등성 평가
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  • 탈리플루메이트 제제에 대한 생물학적동등성 평가
  • Bioequivalence Study on Two Talniflumate Preparations Commercially Available in Korean
저자명
손의동,정지훈,김경태,조영래,민영실,송현주,제현동,임성혁,신용규,조성완,Sohn. Uy-Dong,Jeong. Ji-Hoon,Kim. Kyung-Tae,Cho. Young-Rae,Min. Young-Sil,Song. Hyun-Ju,
간행물명
한국임상약학회지
권/호정보
2006년|16권 2호|pp.101-106 (6 pages)
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한국임상약학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

The aim of the present study was to evaluate the bioequivalence of two talniflumate preparations. We used Somalgen tablet (Kun Wha Pharmaceutical Co., Korea.) as a reference drug for bioequivalence of Crimain tablet (Samjini Pharmaceutical Ind. Co., Korea), and performed this whole study according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male volunteers, $22.8{pm}2.2$ years in age and $64.6{pm}5.3;kg$ in body weight, were divided into two groups and a randomized $2{ imes}2$ cross-over study was employed. After one tablet containing 370 mg of talniflumate was orally administered, blood was taken at predetermined time intervals and the concentrations of talniflumate in plasma were determined using HPLC method with UV-detector. The analysis system was validated in specificity, accuracy, precision and linearity. These items of the analysis condition in this study conform to the guideline of KFDA. The pharmacokinetic parameters such as $AUC_t;and;C_{max}$ were calculated using the analysis condition we established and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$ and Cmax. $Mean{pm}SD$ of reference drug and test drug in $AUC_t;and;C_{max}$ value were $1.27{pm}0.58;({mu}g/ml{cdot}hr);and;0.27{pm}0.13;({mu}g/ml)$ and $1.14{pm}0.46;({mu}g/ml{cdot}hr);and;0.26{pm}0.10;({mu}g/ml)$ respectively. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log (1.25) for $AUC_t;and;C_{max}$, respectively. These results indicate that Samjin talniflumate tablet is bioequivalent to reference drug, Somalgen tablet.