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Article Title

A comparative bioavailability study on two brands of cisapride tablets using univariate and multivariate statistical methods

Abstract

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 C(max) (61.97 ± 13.11 and 64.89 ± 14.31 ng/ml, ± SD), partial AUC (AUC(t), 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), T(1/2) (7.8 ± 1.9 and 7.2 ± 1.8 h), T(max) (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 (C(max), AUC(t), AUC, lnC(max), lnAUCt and lnAUC) were analyzed by univariate statistical methods of the power of test of 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% (C(max) and AUC) and 92% (lnC(max) and lnAUC); whereas overall similarity was 86% (C(max), AUC and MRT) and 76% (lnC(max), lnAUC and lnMRT), respectively. The T(max) obtained in this study was comparable to that reported in Caucasian subjects, but C(max) and AUC were smaller in Chinese.

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