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Effects of age, gender, and race/ethnicity on the pharmacokinetics of posaconazole in healthy volunteers.

机译:年龄,性别和种族/民族对健康志愿者中泊沙康唑药代动力学的影响。

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摘要

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 two studies on healthy adult subjects (>or=18 years of age). Additionally, we explored the effect of P-glycoprotein expression and MDR1 genotype on posaconazole pharmacokinetics in black and 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 for 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.
机译:泊沙康唑是一种三唑类抗真菌药,用于预防侵袭性真菌感染和治疗口咽念珠菌病。在两项针对健康成人受试者(≥18岁)的研究中,我们评估了性别,年龄和种族/种族(黑人或白人)对泊沙康唑稳态药代动力学的影响。此外,我们探索了P-糖蛋白表达和MDR1基因型对黑白受试者中泊沙康唑药代动力学的影响。年龄,性别和种族/族裔对泊沙康唑的药代动力学没有临床相关影响。没有发现任何MDR1单核苷酸多态性与泊沙康唑浓度-时间曲线下的面积相关。泊沙康唑无论年龄,性别或种族/民族,都是安全且耐受性良好的。总之,年龄,性别和种族/民族对健康成人泊沙康唑的稳态药代动力学没有临床影响。因此,基于这些协变量的剂量调整是不必要的。

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