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首页> 外文期刊>The American Journal of Tropical Medicine and Hygiene >Drug-drug interaction analysis of pyronaridine/artesunate and ritonavir in healthy volunteers
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Drug-drug interaction analysis of pyronaridine/artesunate and ritonavir in healthy volunteers

机译：吡咯烷/青蒿琥酯和利托那韦在健康志愿者中的药物-药物相互作用分析

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摘要

A multiple dose, parallel group study was conducted to assess for a drug-drug interaction between the pyronaridine/artesunate (PA) combination antimalarial and ritonavir. Thirty-four healthy adults were randomized (1:1) to receive PA for 3 days or PA with ritonavir (100 mg twice daily for 17 days, PA administered on Days 8-10). Pharmacokinetic parameters for pyronaridine, artesunate, and its active metabolite dihydroartemisinin (DHA) were obtained after the last PA dose and for ritonavir on Days 1 and 10. Ritonavir coadministration did not markedly change pyronaridine pharmacokinetics but resulted in a 27% increase in artesunate area under the curve (AUC) and a 38% decrease in DHA AUC. Ritonavir exposure was increased 3.2-fold in the presence of PA. The only relevant safety observations were increases in liver enzymes, only reaching a clinically significant grade in the PA + ritonavir arm. It was concluded that coadministered ritonavir and PA interact to alter exposure to artesunate, DHA, and ritonavir itself.
机译：进行了多剂量平行组研究，以评估吡咯烷/青蒿琥酯（PA）联合抗疟药和利托那韦之间的药物相互作用。将三十四名健康成年人随机（1：1）接受PA 3天或含利托那韦的PA（100 mg每天两次，共17天，在8-10天服用PA）。在最后一次PA给药后以及第1天和第10天获得了吡那啶，青蒿琥酯及其活性代谢物二氢青蒿素（DHA）的药代动力学参数。利托那韦的共同给药并没有显着改变吡咯烷的药代动力学，但导致青蒿琥酯面积增加了27％曲线（AUC）和DHA AUC降低了38％。在PA存在下，利托那韦的暴露增加了3.2倍。唯一相关的安全性观察是肝酶的升高，仅在PA +利托那韦组达到临床上重要的等级。结论是，共同使用的利托那韦和PA相互作用会改变对青蒿琥酯，DHA和利托那韦本身的接触。

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