Phase 3 pharmacokinetics and safety study of a posaconazole tablet formulation in patients at risk for invasive fungal disease

This Phase 1B study showed that a single tablet of 300 mg of posaconazole, given once daily as prophylaxis to 210 patients at risk for invasive fungal disease, was as safe as that reported for posaconazole oral suspension and achieved steady-state >500 ng/mL for all but one patient.

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Bibliographic Details
Published in	Journal of antimicrobial chemotherapy Vol. 71; no. 3; pp. 718 - 726
Main Authors	Cornely, Oliver A., Duarte, Rafael F., Haider, Shariq, Chandrasekar, Pranatharthi, Helfgott, David, Jiménez, Javier López, Candoni, Anna, Raad, Issam, Laverdiere, Michel, Langston, Amelia, Kartsonis, Nicholas, Van Iersel, Marlou, Connelly, Nancy, Waskin, Hetty
Format	Journal Article
Language	English
Published	England Oxford Publishing Limited (England) 01.03.2016 Oxford University Press
Subjects	Administration, Oral Adolescent Adult Aged Aged, 80 and over Antifungal Agents - administration & dosage Antifungal Agents - adverse effects Antifungal Agents - pharmacokinetics Chemoprevention - adverse effects Chemoprevention - methods Chemotherapy Diarrhea Editor's Choice Female Fungal infections Fungemia - prevention & control Hematologic Neoplasms - complications Humans Immunocompromised Host Male Middle Aged Nausea Original Research Pharmacology Plasma - chemistry Survival Analysis Tablets - administration & dosage Tablets - adverse effects Triazoles - administration & dosage Triazoles - adverse effects Triazoles - pharmacokinetics Young Adult
Online Access	Get full text
ISSN	0305-7453 1460-2091 1460-2091
DOI	10.1093/jac/dkv380

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Summary:	This Phase 1B study showed that a single tablet of 300 mg of posaconazole, given once daily as prophylaxis to 210 patients at risk for invasive fungal disease, was as safe as that reported for posaconazole oral suspension and achieved steady-state >500 ng/mL for all but one patient.
Bibliography:	SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 14 ObjectType-Article-1 ObjectType-Feature-2 content type line 23 Present address: AbbVie Inc., North Chicago, IL, USA.
ISSN:	0305-7453 1460-2091 1460-2091
DOI:	10.1093/jac/dkv380