탈리플루메이트 제제에 대한 생물학적동등성 평가

Abstract

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±2.2 years in age and 64.6±5.3 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 370mg 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 AUCt and Cmax were calculated using the analysis condition we established and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUCt and Cmax. Mean±SD of reference drug and test drug in AUCt and Cmax value were 1.27±0.58 (μg/ml· hr) and 0.27±0.13 (μg/ml) and 1.14±0.46 (μg/ml·hr) and 0.26±0.10 (μg/ml) respectively. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log (1.25) for AUCt and Cmax, respectively. These results indicate that Samjin talniflumate tablet is bioequivalent to reference drug, Somalgen tablet.