UNTERSUCHUNG ZUR BIOAQUIVALENZ VON METOCLOPRAMID IN ZWEI TABLETTENFORMULIERUNGEN

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • D. Dobrev - , Medical Faculty Carl Gustav Carus (Author)
  • A. Berndt - , Medical Faculty Carl Gustav Carus (Author)
  • R. Oertel - , Institute of Clinical Pharmacology (Author)
  • K. Richter - , Medical Faculty Carl Gustav Carus (Author)
  • B. Terhaag - , Medical Faculty Carl Gustav Carus (Author)
  • T. Gramatte - , Medical Faculty Carl Gustav Carus (Author)

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 C(max). A positive decision for bioequivalence was derived from the usual confidence intervals for both parameters. The t(max)-values did not differ significantly. Statistical evaluation of all parameters revealed bioequivalence between the two preparations.

Translated title of the contribution
Bioequivalence of metoclopramide in two tablet formulations

Details

Original languageGerman
Pages (from-to)304-306
Number of pages3
JournalArzneimittel-Forschung/Drug Research
Volume45
Issue number3
Publication statusPublished - 1995
Peer-reviewedYes

External IDs

PubMed 7741790
ORCID /0000-0003-1526-997X/work/142247283

Keywords

ASJC Scopus subject areas

Keywords

  • CAS 363-62-5, Cerucal®, bioequivalence, clinical studies, gastrointestinal drugs, metoclopramide