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조프란 정(온단세트론 8 mg)에 대한 하나 온단세트론 정의 생물학적 동등성
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  • 조프란 정(온단세트론 8 mg)에 대한 하나 온단세트론 정의 생물학적 동등성
저자명
조혜영,김수진,심영순,임동구,오인준,문재동,이용복,Cho. Hea-Young,Kim. Soo-Jin,Shim. Young-Sun,Lim. Dong-Koo,Oh. In-Joon,Moon. Jai-Dong,Lee. Yong-Bok
간행물명
藥劑學會誌
권/호정보
2000년|30권 3호|pp.213-218 (6 pages)
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한국약제학회
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정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

Ondansetron is a potent, highly selective 5-hydroxytryptamine3(5-HT3) receptor- antagonist, for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiography, and the treatment of post-operative nausea and vomiting. The purpose of the present study was to evaluate the bioequivalence of two ondansetron tablets, $Zofran^{TM}$, (Glaxo Wellcome Korea Ltd.) and Hana ondansetron (Hana Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, $23.56{pm}1.79$ year in age and $67.35{pm}8.35;kg$ in body weight, were divided into two groups and a randomized $2{ imes}2$ cross-over study was employed. After one tablet containing 8 mg of ondansetron was orally administered, blood was taken at predetermined time intervals and the concentrations of ondansetron in serum were determined using HPLC with UV detector. 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 were 7.53%, -0.23% and -3.92%, respectively when calculated against the $Zofran^{TM}$, tablet. The powers $(1-{eta})$ for $AUC_t,;C_{max};and;T_{max}$ were above 99.00%, above 99.00% and 84.99%, respectively. Minimum detectable differences $(Delta);at;{alpha}=0.1;and;1-{eta}=0.8$ were all less than 20% (e.g., 12.25%, 10.88% and 18.37% for $AUC_t,;C_{max};and;T_{max}$, respectively). The 90% confidence intervals were all within ${pm}20%$ (e.g., $-0.70{sim}15.76,;-7.53{sim}7.08;and;-16.27{sim}8.42;for;AUC_t,;C_{max};and;T_{max}$, respectively). All of the above parameters met the criteria of KFDA for bioequivalence, indicating that Hana ondansetron tablet is bioequivalent to $Zofran^{TM}$, tablet.