Literature DB >> 7741790

[The bioequivalence of metoclopramide in two tablet formulations].

D Dobrev1, A Berndt, R Oertel, K Richter, B Terhaag, T Gramatté.   

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.

Entities:  

Mesh:

Substances:

Year:  1995        PMID: 7741790

Source DB:  PubMed          Journal:  Arzneimittelforschung        ISSN: 0004-4172


  1 in total

1.  Comparison of the pharmacokinetics of a new 30 mg modified-release tablet formulation of metoclopramide for once-a-day administration versus 10 mg immediate-release tablets: a single and multiple-dose, randomized, open-label, parallel study in healthy male subjects.

Authors:  Roberto Bernardo-Escudero; Rosalba Alonso-Campero; María Teresa de Jesús Francisco-Doce; Myriam Cortés-Fuentes; Miriam Villa-Vargas; Juan Angeles-Uribe
Journal:  Eur J Drug Metab Pharmacokinet       Date:  2012-02-11       Impact factor: 2.441

  1 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.