Sansone-Parsons Angela, Krishna Gopal, Simon Jason, Soni Peter, Kantesaria B, Herron Jerry, Stoltz Randall
Schering-Plough Research Institute, K15-4-4455, 2015 Galloping Hill Rd., Kenilworth, NJ 07033, USA.
Antimicrob Agents Chemother. 2007 Feb;51(2):495-502. doi: 10.1128/AAC.00472-06. Epub 2006 Nov 13.
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.
泊沙康唑是一种三唑类抗真菌药物，用于预防侵袭性真菌感染和治疗口咽念珠菌病。我们在两项针对健康成年受试者（≥18岁）的研究中评估了性别、年龄和种族/民族（黑人或白人）对泊沙康唑稳态药代动力学的影响。此外，我们还探讨了P-糖蛋白表达和MDR1基因型对黑人和白人受试者中泊沙康唑药代动力学的影响。年龄、性别和种族/民族对泊沙康唑药代动力学无临床相关影响。未观察到任何MDR1单核苷酸多态性与泊沙康唑浓度-时间曲线下面积之间存在关联。无论年龄、性别或种族/民族如何，泊沙康唑均安全且耐受性良好。总之，年龄、性别和种族/民族对健康成年人中泊沙康唑的稳态药代动力学无临床相关影响；因此，无需基于这些协变量进行剂量调整。
