The bioequivalence of metoclopramide in two tablet formulations

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.