[The bioequivalence of metoclopramide in two tablet formulations].
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.
Dobrev
D
D
Institut für Klinische Pharmakologie, Medizinische Fakultät der Technischen Universität Dresden.
Berndt
A
A
Oertel
R
R
Richter
K
K
Terhaag
B
B
Gramatté
T
T
D000328:Adult; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D008297:Male; D008787:Metoclopramide / Q000008:administration & dosage / Q000493:pharmacokinetics*; D013607:Tablets; D013810:Therapeutic Equivalency
D013607:Tablets; D008787:Metoclopramide
Untersuchung zur Bioäquivalenz von Metoclopramid in zwei Tablettenformulierungen.