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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Effect of verapamil on the pharmacokinetics of aliskiren in healthy participants.
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Effect of verapamil on the pharmacokinetics of aliskiren in healthy participants.

机译：维拉帕米对健康参与者阿利吉仑药代动力学的影响。

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摘要

The authors describe the drug-drug interaction between aliskiren and verapamil in healthy participants. Eighteen participants first received an oral dose of aliskiren 300 mg (highest recommended clinical dose) in period 1. After a 10-day washout period, the participants received verapamil 240 mg/d for 8 days (period 2). On day 8, the participants also received an oral dose of aliskiren 300 mg. Safety and pharmacokinetic analyses were performed during each treatment period. Concomitant administration of a single dose of aliskiren during steady-state verapamil resulted in an increase in plasma concentration of aliskiren. The mean increase in AUC(0-infinity), AUC(last), and C(max) was about 2-fold. On day 8, in the presence of aliskiren, AUC(tau,ss) of R-norverapamil, R-verapamil, S-norverapamil, and S-verapamil was decreased by 10%, 16%, 10%, and 25%, respectively. Similarly, the C(max,ss) of R-norverapamil, R-verapamil, S-norverapamil, and S-verapamil was decreased by 13%, 18%, 12%, and 24%, respectively. Aliskiren did not affect the AUC(tau,ss) ratios of R-norverapamil/R-verapamil and S-norverapamil/S-verapamil. Aliskiren administered alone or in combination with verapamil was well tolerated in healthy participants. In conclusion, no dose adjustment is necessary when aliskiren is administered with moderate ABCB1 inhibitors such as verapamil (240 mg/d).
机译：作者描述了健康参与者中阿利吉仑和维拉帕米之间的药物相互作用。 18名参与者在第1阶段首先接受阿利吉仑300 mg（建议的最高临床剂量）的口服剂量。在10天的清除期后，参与者接受了8天（2期）的维拉帕米240 mg / d。在第8天，参与者还接受了阿利吉仑300 mg的口服剂量。在每个治疗期间进行安全性和药代动力学分析。在稳态维拉帕米期间同时服用单剂量的阿利吉仑会导致阿利吉仑的血浆浓度升高。 AUC（0-无穷大），AUC（last）和C（max）的平均增加约为2倍。在第8天，在存在阿利吉仑的情况下，R-去甲拉帕米，R-维拉帕米，S-去甲拉帕米和S-维拉帕米的AUC（tau，ss）分别降低了10％，16％，10％和25％。 。同样，R-去甲拉帕米，R-拉拉帕米，S-去甲拉帕米和S-拉拉帕米的C（max，ss）分别降低了13％，18％，12％和24％。 Aliskiren不会影响R-去甲维拉帕米/ R-维拉帕米和S-去甲维拉帕米/ S-维拉帕米的AUC（tau，ss）比率。在健康参与者中，单独或与维拉帕米联用的Aliskiren耐受良好。总之，当阿利吉仑与中度ABCB1抑制剂（如维拉帕米（240 mg / d））一起给药时，无需调整剂量。

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