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연구논문 : 생명과학 ; 폴록사머 188 및 멘톨에 의한 쥐에서의 이부프로펜의 직장 생체이용율의 증가
용철순 ( Chul Soon Yong ),양재하 ( Chae Ha Yang ),이종달 ( Jong Dal Rhee ),이범진 ( Beom Jin Lee ),김동출 ( Dong Chool Kim ),김대덕 ( Dae Duk Kim ),김종국 ( Chong Kook Kim ),최진석 ( Jun Shik Choi ),최한곤 ( Han Gon Choi ) 영남대학교 약품개발연구소 2004 영남대학교 약품개발연구소 연구업적집 Vol.14 No.-
프레탈^(R)정(실로스타졸 50mg)에 대한 실로졸^(R)정의 생물학적 동등성
최한곤,권기철,이승호,김학미,박병주,유봉규,이종달,이경희,하정희,우종수,박인숙,최진석,용철순 한국병원약사회 2003 병원약사회지 Vol.20 No.1
Bioequivalence of two cilostazol tablets, the Pletaal^(R)(Korea Otsuka Pharmaceutical Co., Ltd.) and the Cilozol^(R)(Hanmi Pharmaceutical Co., Ltd.), was evaluated according to the guideline of KFDA, Sixteen normal male volunteers(age 20~29 years old) were divided into two groups and a randomized 22 cross-over study was employed. After two tablets containing 50㎎ of cilostazol were orally administered. blood was taken at predetermined time intervals and the concentration of cilostazol in plasma was determined with an HPLC method using UV detector. The pharmacokinetic parameters(C_(max), T_(max) and AUC_(t)) were calculated and ANOVA was utilized for the statistical analysis of parameters. The results showed that the differences in C_(max), T_(max) and AUC_(t) between two tablets were 4.99%, 1.74% and 7.68%, respectively. The powers(1-β) for C_(max), T_(max) and AUC_(t) were83.92%, 80.12% and 85.03%, respectively. Detectable differences(Δ) and confidence intervals were all less than 20%, and confidence interval of all the parameters were also less than 20% at the significance level(α) of 0.05. All of these parameters met the criteria of KFDA for bioequivalence, indicating that Cilozol^(R) tablet is bioequivalent to Pletaal^(R) tablet.