年龄、性别和种族/民族对泊沙康唑在健康志愿者体内药代动力学的影响。
Effects of age, gender, and race/ethnicity on the pharmacokinetics of posaconazole in healthy volunteers.
作者信息
Sansone-Parsons Angela, Krishna Gopal, Simon Jason, Soni Peter, Kantesaria B, Herron Jerry, Stoltz Randall
机构信息
Schering-Plough Research Institute, K15-4-4455, 2015 Galloping Hill Rd., Kenilworth, NJ 07033, USA.
出版信息
Antimicrob Agents Chemother. 2007 Feb;51(2):495-502. doi: 10.1128/AAC.00472-06. Epub 2006 Nov 13.
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 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.
摘要
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。
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Treatment of invasive aspergillosis with posaconazole in patients who are refractory to or intolerant of conventional therapy: an externally controlled trial.泊沙康唑治疗对传统疗法难治或不耐受的侵袭性曲霉病患者：一项外部对照试验。
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Disposition of posaconazole following single-dose oral administration in healthy subjects.健康受试者单剂量口服泊沙康唑后的处置情况。
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Effect of food on the relative bioavailability of two oral formulations of posaconazole in healthy adults.食物对泊沙康唑两种口服制剂在健康成年人中的相对生物利用度的影响。
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