UNTERSUCHUNG ZUR BIOAQUIVALENZ VON METOCLOPRAMID IN ZWEI TABLETTENFORMULIERUNGEN
Publikation: Beitrag in Fachzeitschrift › Forschungsartikel › Beigetragen › Begutachtung
Beitragende
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.
Details
Originalsprache | Deutsch |
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Seiten (von - bis) | 304-306 |
Seitenumfang | 3 |
Fachzeitschrift | Arzneimittel-Forschung/Drug Research |
Jahrgang | 45 |
Ausgabenummer | 3 |
Publikationsstatus | Veröffentlicht - 1995 |
Peer-Review-Status | Ja |
Externe IDs
PubMed | 7741790 |
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ORCID | /0000-0003-1526-997X/work/142247283 |
Schlagworte
ASJC Scopus Sachgebiete
Schlagwörter
- CAS 363-62-5, Cerucal®, bioequivalence, clinical studies, gastrointestinal drugs, metoclopramide