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스프렌딜 지속정(펠로디핀 5 mg)에 대한 스타핀 지속정의 생물학적동등성
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  • 스프렌딜 지속정(펠로디핀 5 mg)에 대한 스타핀 지속정의 생물학적동등성
저자명
조혜영,강현아,이석,백승희,박은자,최후균,문재동,이용복,Cho. Hea-Young,Kang. Hyun-Ah,Lee. Suk,Baek. Seung-Hee,Park. Eun-Ja,Choi. Hoo-Kyun,Moon. Jai-Dong,
간행물명
藥劑學會誌
권/호정보
2003년|33권 4호|pp.311-317 (7 pages)
발행정보
한국약제학회
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정기간행물|
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기타
이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

Felodipine is a calcium antagonist that lowers blood pressure by reducing peripheral resistance by meas of a direct, selective action on smooth muscle in arterial resistance vessels. Futhermore, it have been approved for the effective in angina pectoris and cardiac failure. The purpose of the present study was to evaluate the bioequivalence of two felodipine extended release (ER) tablets, Splendil (YuHan Corporation) and Stapin (Hana Pharmaceutial Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The felodipine release from the two felodipine formulations in vitro was tested using KP VIII Apparatus II method at pH 6.5 buffer solution. Twenty six healthy male subjects, $22.73{pm}1.78$ years in age and $66.66{pm}7.28;kg$ in body weight, were divided into two groups and a radomized $2{ imes}2$ cross-over study was employed. After two tablets containing 5 mg as felodipine were orally administered, blood sample was taken at predetermined time intervals and the concentrations of felodipine in serum were determined using column-switching HPLC method with UV detector. The dissolution profiles of two formulations were similar at pH 6.5 buffer solution. 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 using logarithmically transformed $AUC_t;and;C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the Splendil were 2.53%, 1.32% and 18.32% for $AUC_t,;C_{max};and;T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance rage of log(0.86) to log(1.25) $(e.g.,;log(0.86){sim}log(1.20);and;log(0.89){sim}log(1.23);for;AUC_t,;C_{max},;respectively)$. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Stapin ER tablet and Splendil ER tablet are bioequivalent.