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무코스타 정(레바미피드 100 mg)에 대한 레바미드 정의 생물학적 동등성
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  • 무코스타 정(레바미피드 100 mg)에 대한 레바미드 정의 생물학적 동등성
저자명
조혜영,정현철,오인준,문재동,이용복,Cho. Hea-Young,Jeong. Hyun-Cheol,Oh. In-Joon,Moon. Jai-Dong,Lee. Yong-Bok
간행물명
藥劑學會誌
권/호정보
2001년|31권 4호|pp.281-287 (7 pages)
발행정보
한국약제학회
파일정보
정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

Rebamipide is a novel anti-gastric ulcer agent that has been reported to increase the synthesis of mucus, to increase the mucosal concentration of prostaglandin, and to promote rapid ulcer healing. The purpose of the present study was to evaluate the bioequivalence of two rebamipide tablets, $Mucosta^{TM}$ (Otsuka Korea Pharmaceutical Co., Ltd.) and $Rebamide^{TM}$ (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The rebamipide release from the two rebamipide tablets in vitro was tested using KP VII Apparatus II method at pH 6.8 dissolution media. Twenty normal male volunteers, $24.20{pm}2.26$ years in age and $66.19{pm}9.41;kg$ in body weight, were divided into two groups and a randomized $2{ imes}2$ cross-over study was employed. After one tablet containing 100 mg of rebamipide was orally administered, blood was taken at predetermined time intervals and the concentrations of rebamipide in serum were determined using HPLC method with fluorescence detector. The dissolution profiles of two rebamipide tablets were very similar at pH 6.8 dissolution media. Besides, the pharmacokinetic parameters such as $AUC_t$, $C_{max};and;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in $AUC_t$, $C_{max};and;T_{max}$ between two tablets based on the $Mucosta^{TM}$ were -2.57%, 5.77% and -1.47%, respectively. Minimum detectable differences $({Delta})$ at ${alpha}=0.05$ and $1-{eta}=0.8$ were less than 20% (e.g., 12.62% and 17.63% for $AUC_t,;and;C_{max}$, respectively). The powers $(1-{eta})$ at ${alpha}=0.05$, ${Delta}=0.2$ for $AUC_t;and;C_{max}$ were above 99.00% and 88.56%, respectively. The 90% confidence intervals were within ${pm}20%$ (e.g., $-9.96{sim}4.82$ and $-4.54{sim}16.09$ for $AUC_t;and;C_{max}$, respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that $Rebamide^{TM}$ tablet is bioequivalent to $Mucosta^{TM}$ tablet.