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프로스카 정(피나스테리드 5 mg)에 대한 푸로케어 정의 생물학적동등성
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  • 프로스카 정(피나스테리드 5 mg)에 대한 푸로케어 정의 생물학적동등성
저자명
강현아,조혜영,이용복,Kang. Hyun-Ah,Cho. Hea-Young,Lee. Yong-Bok
간행물명
藥劑學會誌
권/호정보
2006년|36권 2호|pp.143-148 (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

Finasteride $[N-(1, 1-dimethylethyl)-3-oxo-4-aza-5{alpha}-androst-1-ene-17{eta}-carboxamide]$ is a 4-aza-3-oxosteroidal inhibitor of human $5{alpha}-reductase$. The purpose of the present study was to evaluate the bioequivalence of two finasteride tablets, $Proscar^{circledR}$ (MSD Korea Ltd.) and Procare (Hana Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of finasteride from the two finasteride formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, $23.7;{pm};2.24$ years in age and $67.2;{pm};8.55;kg$ in body weight, were divided into two groups and a randomized $2;{ ime};2$ cross-over study was employed. After two tablets containing 5 mg as finasteride was orally administered, blood samples were taken at predetermined time intervals and the concentrations of finasteride in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar in all tested dissolution media. 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 $AUC_t,;C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Proscar^{circledR}$, were 6.39, 4.65 and -13.9% 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 range of log 0.800 to log 1.25 $(e.g.,;log;0.990{sim}log;1.14;and;log;0.977{sim}log;1.13 for;AUC_t;and;C_{max},;respectively)$. Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Procare tablet was bioequivalent to $Proscar^{circledR}$ tablet.