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[The bioequivalence of metoclopramide in two tablet formulations].

作者信息

Dobrev D, Berndt A, Oertel R, Richter K, Terhaag B, Gramatté T

机构信息

Institut für Klinische Pharmakologie, Medizinische Fakultät der Technischen Universität Dresden.

出版信息

Arzneimittelforschung. 1995 Mar;45(3):304-6.

PMID:7741790
Abstract

An investigation on the bioavailability of a tablet with 10 mg metoclopramide-HCl (CAS 363-62-5) Cerucal was performed in a two-way cross-over study with 12 volunteers. Metoclopramide was determined in serum by HPLC. The relative bioavailability (mean and nonparametric 95% confidence interval) with respect to a reference preparation was 0.95 (95% CI 0.88-1.02) for AUC and 0.92 (95% CI 0.79-1.07) for Cmax. A positive decision for bioequivalence was derived from the usual confidence intervals for both parameters. The tmax-values did not differ significantly. Statistical evaluation of all parameters revealed bioequivalence between the two preparations.

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