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비유피-4 정(염산프로피베린 20 mg)에 대한 건일염산프로피베린 정의 생물학적동등성
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  • 비유피-4 정(염산프로피베린 20 mg)에 대한 건일염산프로피베린 정의 생물학적동등성
저자명
조혜영,박은자,강현아,백승희,김세미,박찬호,오인준,문재동,이용복,Cho. Hea-Young,Park. Eun-Ja,Kang. Hyun-Ah,Baek. Seung-Hee,Kim. Se-Mi,Park. Chan-Ho,Oh. In-Jo
간행물명
藥劑學會誌
권/호정보
2004년|34권 5호|pp.419-425 (7 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

The purpose of the present study was to evaluate the bioequivalence of two propiverine hydrochloride tablets, BUP-4 (Jeil Pharm. Co., Ltd.) and Kuhnil Propiverine Hydrochloride (Kuhnil Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The propiverine release from the two propiverine hydrochloride formulations in vitro was tested using KP VIII Apparatus II method with a variety of dissolution media (pH 1.2, 4.0, 6.8 buffer solutions, water and blend of polysorbate 80 into pH 6.8). Twenty six healthy male subjects, $23.73{pm}2.79$ years in age and $67.04{pm}7.93;kg$ in body weight, were divided into two groups and a randomized $2;{ imes};2$ cross-over study was employed. After one tablet containing 20 mg as propiverine hydrochloride was orally administered, blood was taken at predetermined time intervals and the concentrations of propiverine in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all 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 using logarithmically transformed $AUC_t,;C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the BUP-4 were 0.17%, 7.98% and 4.55% 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(0.8) to log(1.25) $(e.g.,;log(0.88){sim}log(1.l2);and;log(0.90){sim}log(1.l5);for;AUC_t;and;C_{max},;respectively)$. Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Kuhnil Propiverine Hydrochloride tablet was bioequivalent to BUP-4 tablet.