Evaluation of the bioequivalence and food effect on the bioavailability of CC-486 (oral azacitidine) tablets in adult patients with cancer.
Bioequivalence
CC-486
Oral azacitidine
Pharmacokinetics
Journal
Cancer chemotherapy and pharmacology
ISSN: 1432-0843
Titre abrégé: Cancer Chemother Pharmacol
Pays: Germany
ID NLM: 7806519
Informations de publication
Date de publication:
03 2020
03 2020
Historique:
received:
28
09
2019
accepted:
22
01
2020
pubmed:
10
2
2020
medline:
10
2
2020
entrez:
10
2
2020
Statut:
ppublish
Résumé
CC-486 is an oral formulation of azacitidine that allows for extended dosing schedules to prolong azacitidine exposure to malignant cells and maximize clinical activity. CC-486 300 mg daily, administered for 14 or 21 days of 28-day treatment cycles, is currently under investigation in two ongoing phase III trials. The 300-mg daily dose in these studies is administered as two 150-mg tablets (Formulation A). We evaluated the bioequivalence of one 300-mg CC-486 tablet (Formulation B) with Formulation A and food effect on Formulation B, in adult patients with cancer in a 2-stage crossover design study. The ratios of the geometric means of the maximum azacitidine plasma concentration (C The single 300-mg CC-486 tablet was bioequivalent to two 150-mg tablets, which have shown to be efficacious and generally well-tolerated in clinical trials, and can be taken with or without food.
Identifiants
pubmed: 32036412
doi: 10.1007/s00280-020-04037-9
pii: 10.1007/s00280-020-04037-9
pmc: PMC7036073
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
621-626Subventions
Organisme : NCI NIH HHS
ID : R01 CA224917
Pays : United States
Commentaires et corrections
Type : ErratumIn
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