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카두라 정(독사조신 2 mg)에 대한 카르딜 정의 생물학적 동등성
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  • 카두라 정(독사조신 2 mg)에 대한 카르딜 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 1호|pp.61-65 (5 pages)
발행정보
한국약제학회
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정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

Doxazosin, a postsynaptic selective ${alpha}1-adrenoceptor$ antagonist, is a potent antihypertensive agent which reduces peripheral resistance and blood pressure by vasodilatation of peripheral vessels. It is also used in the treatment of urinary obstruction by benign prostatic hypertrophy. The purpose of the present study was to evaluate the bioequivalence of two doxazosin tablets, $Cardura^{TM}$ (Pfizer Korea Ltd.) and $Cardil^{TM};$ (Kyungdong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen normal male volunteers, $24.19{pm}2.48$ years in age and $62.41{pm}6.66$ kg in body weight, were divided into two groups and a randomized $2{ imes}2$ cross-over study was employed. After one tablet containing 2 mg of doxazosin was orally administered, blood was taken at predetermined time intervals and the concentrations of doxazosin in serum were determined with an HPLC method using spectrofluorometric 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 -1.54%, -1.51 % and 3.42%, respectively, when calculated against the $Cardura^{TM}$ tablet. The powers $(1-{eta})$ for $AUC_t,;C_{max};and;T_{max}$ were all more than 99.00%. Minimum detectable differences $(Delta)$ at ${alpha}=0.05;and;1-{eta}=0.8$ were all less than 20% (e.g., 12.73%, 12.84% and 13.01% for $AUC_t,;C_{max};and;T_{max}$, respectively). The 90% confidence intervals were all within :${pm}20%$ (e.g., $-8.97{sim}5.90,;-9.01{sim}6.00;and;-4.16{sim}11.05;for;AUC_t,;C_{max};and;T_{max},;respectively)$. All of the above para- meters met the criteria of KFDA for bioequivalence, indicating that $Cardil^{TM}$ tablet is bioequivalent to $Cardura^{TM}$ tablet.