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首页> 外文期刊>Antimicrobial agents and chemotherapy. >Pharmacokinetic interaction study of ritonavir-boosted saquinavir in combination with rifabutin in healthy subjects.
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Pharmacokinetic interaction study of ritonavir-boosted saquinavir in combination with rifabutin in healthy subjects.

机译：利托那韦增强的沙奎那韦与利福布汀在健康受试者中的药代动力学相互作用研究。

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The effect of multiple doses of rifabutin (150 mg) on the pharmacokinetics of saquinavir-ritonavir (1,000 mg of saquinavir and 100 mg of ritonavir [1,000/100 mg]) twice daily (BID) was assessed in 25 healthy subjects. Rifabutin reduced the area under the plasma drug concentration-time curve from 0 to 12 h postdose (AUC(0-12)), maximum observed concentration of drug in plasma (C(max)), and minimum observed concentration of drug in plasma at the end of the dosing interval (C(min)) for saquinavir by 13%, 15%, and 9%, respectively, for subjects receiving rifabutin (150 mg) every 3 days with saquinavir-ritonavir BID. No effects of rifabutin on ritonavir AUC(0-12), C(max), and C(min) were observed. No adjustment of the saquinavir-ritonavir dose (1,000/100 mg) BID is required when the drugs are administered in combination with rifabutin. The effect of multiple doses of saquinavir-ritonavir on rifabutin pharmacokinetics was evaluated in two groups of healthy subjects. In group 1 (n = 14), rifabutin (150 mg) was coadministered every 3 days with saquinavir-ritonavir BID. The AUC(0-72) and C(max) of the active moiety (rifabutin plus 25-O-desacetyl-rifabutin) increased by 134% and 130%, respectively, compared with administration of rifabutin (150 mg) once daily alone. Rifabutin exposure increased by 53% for AUC(0-72) and by 86% for C(max). In group 3 (n = 13), rifabutin was coadministered every 4 days with saquinavir-ritonavir BID. The AUC(0-96) and C(max) of the active moiety increased by 60% and 111%, respectively, compared to administration of 150 mg of rifabutin once daily alone. The AUC(0-96) of rifabutin was not affected, and C(max) increased by 68%. Monitoring of neutropenia and liver enzyme levels is recommended for patients receiving rifabutin with saquinavir-ritonavir BID.
机译：在25名健康受试者中，评估了每天两次（BID）多次服用利福布汀（150 mg）对沙奎那韦-利托那韦（1,000 mg沙奎那韦和100 mg利托那韦[1,000 / 100 mg]）药代动力学的影响。利福布汀将血浆药物浓度-时间曲线下的面积从给药后0到12小时（AUC（0-12）），血浆中观察到的最大药物浓度（C（max））和血浆中观察到的最小药物浓度降低了对于每3天接受沙奎那韦-利托那韦BID接受利福布汀（150 mg）的受试者，沙奎那韦的给药间隔（C（min））结束分别减少13％，15％和9％。没有观察到利福布丁对利托那韦AUC（0-12），C（最大）和C（最小）的影响。当药物与利福布汀联用时，无需调整沙奎那韦-利托那韦剂量（1,000 / 100 mg）的BID。在两组健康受试者中评估了多剂量沙奎那韦-利托那韦对利福布汀药代动力学的影响。在第1组（n = 14）中，利福布汀（150 mg）每3天与沙奎那韦-利托那韦BID共同给药。活性成分（利福布丁加25-O-去乙酰基利福布丁）的AUC（0-72）和C（max）分别比每天一次施用利福布丁（150 mg）分别增加134％和130％。对于AUC（0-72），利福布汀的暴露量增加了53％，对于C（max），其暴露量增加了86％。在第3组（n = 13）中，利福布汀与沙奎那韦-利托那韦BID每4天共同给药。与每天一次单独服用150 mg的利福布汀相比，活性部分的AUC（0-96）和C（max）分别增加60％和111％。利福布汀的AUC（0-96）不受影响，C（max）增加68％。对于接受利福布汀联合沙奎那韦-利托那韦BID的患者，建议监测中性粒细胞减少和肝酶水平。

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