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AAC Accepts, published online ahead of print on 13 November 2006
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Antimicrob. Agents Chemother. doi:10.1128/AAC.00472-06
Copyright (c) 2006, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

Effects of Age, Gender, and Race/Ethnicity on the Pharmacokinetics of Posaconazole in Healthy Volunteers

Angela Sansone-Parsons*, Gopal Krishna, Jason Simon, Peter Soni, B. Kantesaria, Jerry Herron, and Randall Stoltz

Schering-Plough Research Institute, Kenilworth, New Jersey, Research Solutions, Little Rock, Arkansas, and Covance GFI Research, Evansville, Indiana

* To whom correspondence should be addressed. Email: angela.sansone{at}spcorp.com,


   Abstract

Posaconazole is a triazole antifungal for prophylaxis of invasive fungal infection and treatment of oropharyngeal candidiasis. We evaluated the effects of gender, age, and race/ethnicity (black or white) on the steady state pharmacokinetics of posaconazole in 2 studies on healthy adult subjects (≥18 years of age). Additionally, they explored the effect of P-glycoprotein (P-gp) expression and MDR1 genotype on posaconazole pharmacokinetics in black and in white subjects. Age, gender, and race/ethnicity had no clinically relevant effects on posaconazole pharmacokinetics. No association was observed between any MDR1 single nucleotide polymorphism and the area under the concentration-time curve of posaconazole. Posaconazole was safe and well tolerated regardless of age, gender, or race/ethnicity. In conclusion, age, gender, and race/ethnicity have no clinically relevant effects on the steady state pharmacokinetics of posaconazole in healthy adults; therefore, dosage adjustments based on these covariates are unnecessary.




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