원문정보
초록
영어
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, years in age and in body weight, were divided into two groups and a randomized 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 were calculated using the analysis condition we established and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed and Cmax. of reference drug and test drug in value were and respectively. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log (1.25) for , respectively. These results indicate that Samjin talniflumate tablet is bioequivalent to reference drug, Somalgen tablet.
목차
연구방법
피험자 선정
피험자 관리, 약물의 투약 및 혈액 채취
시약 및 기기
검량선 작성 및 혈증 탈니플누메이트의 정량
생물학적 동등성 평가
연구결과 및 고찰
피험자의 선정
분석법의 개발 및 검증
생체이용률 파라미터의 산출
시험결과의 통계처리
감사의 말씀
참고문헌