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題 名 | A Comparative Bioavailability Study on Two Brands of Cisapride Tablets Using Univariate and Multivariate Statistical Methods=以單變項和多變項統計解析法檢定二種廠牌的Cisapride錠劑之生體可用率 |
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作 者 | 許如玉; 許美玉; 許興智; 羅昌霞; 王寵富; 陳本全; 陸重隆; | 書刊名 | 藥物食品分析 |
卷 期 | 6:4 1998.12[民87.12] |
頁 次 | 頁703-711 |
分類號 | 418.632 |
關鍵詞 | 藥物動力學; 生體相等性; 多變項統計解析; Cisapride; Tablets; Chinese; Bioavailability; Multivariate analysis; |
語 文 | 英文(English) |
英文摘要 | A comparative bioavailability study on the original inventor's (Prepulsid, Janssen) and a generic (Cisapride, Swiss Pharm. Taiwan) cisapride tablets was carried out using a single dose, 2x2 randomized crossover design with 16 normal Chinese males. The pharmacokinetic parameters of cisapride obtained following oral administration of 20 mg dose of Prepulsid and Cisapride tablets were Cmax (61.97± 13.11 and 64.89±14.31 ng/ml, mean±SD), partial AUC (AUCt, 402±121.4 and 405.4± 117.5 ng.h/ml), total AUC (420.8 ±123.8 and 421.9±118.0 ng .h/ml), T1/2 (7.8±1.9 and 7.2±1.8 h), Tmax (1.3±0.5 and 1.2±0.5 h), MRT (8.5±1.7 and 8.1±1.4 h), VRT (102.0±42.6 and 87.4±41.3 h2) and Cl/F (853.1±238.9 and 850.4±240.7 ml/min), respectively. The bioavailability parameters (Cmax, AUCt, AUC, lnCmax, lnAUCt and lnAUC) were analyzed by univariate statistical methods of the power of test to detect a 20% difference, 90% confidence interval, FDA's two one-sided tests and 90% joint confidence region. The results show that the two brands of cisapride tablet are bioequivalent based on current bioequivalence criteria. Overall similarity in bioavailability between the two products determined by multivariate statistical method was 94% (Cmax and AUC) and 92% (lnCmax and lnAUC); whereas overall similarity was 86% (Cmax, AUC and MRT) and 76% (lnCmax, lnAUC and lnMRT), respectively. The Tmax obtained in this study was comparable to that reported in Caucasian subjects, but Cmax and AUC were smaller in Chinese. |
本系統中英文摘要資訊取自各篇刊載內容。