Pharmacokinetic comparison of orally-disintegrating metoclopramide with conventional metoclopramide tablet formulation in healthy volunteers

Autor:	Ronnie Fass, H. J. Pieniaszek, J. R. Thompson
Rok vydání:	2009
Předmět:	Adult Male Metoclopramide Adolescent medicine.drug_class Nausea Cmax Administration Oral Bioequivalence Medication Adherence Young Adult Oral administration medicine Antiemetic Humans Pharmacology (medical) Gastroparesis Cross-Over Studies Hepatology business.industry Gastroenterology Middle Aged medicine.disease Crossover study Therapeutic Equivalency Anesthesia Gastroesophageal Reflux Female medicine.symptom business Deglutition Disorders medicine.drug Tablets
Zdroj:	Alimentary pharmacologytherapeutics. 30(3)
ISSN:	1365-2036
Popis:	Summary Background Oral tablet formulations of metoclopramide are effective therapies for gastroparesis and gastro-oesophageal reflux disease; however, difficulty swallowing tablets or nausea/vomiting may reduce patient adherence to therapy. Because of this, a metoclopramide orally-disintegrating tablet (ODT) has been developed. Aim To evaluate the bioequivalence of a single administration of a 10-mg metoclopramide ODT and a conventional 10-mg oral metoclopramide tablet in healthy volunteers. Methods In a randomized, single-dose, crossover study, healthy volunteers received single administration of 10-mg metoclopramide ODT and 10-mg conventional metoclopramide tablet, with a 7-day interval between treatments. Serial blood samples were collected before dosing and during 24 h post-treatment. Results Forty-one volunteers completed both treatment arms. Metoclopramide ODT was bioequivalent to conventional tablets; 90% CIs for geometric mean treatment ratios of Cmax [91.6% (90% CI, 87.7–95.8%)], AUClast [97.3% (90% CI, 94.5–100.2%)] and AUCinf [97.6% (90% CI, 94.5–100.8%)] were within the predefined range. Of the 44 volunteers included in the safety analysis, 9 (20%) reported AEs after ODT, compared with 13 (30%) after conventional tablets. Conclusion In healthy volunteers, single administration of 10-mg metoclopramide ODT was well tolerated and bioequivalent to single administration of a conventional 10-mg metoclopramide tablet.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::43f1e8765ebe0b158a9a2d5949e5530f https://pubmed.ncbi.nlm.nih.gov/19459829 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
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