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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Single- and multiple-dose pharmacokinetics of levovirin valinate hydrochloride (R1518) in healthy volunteers.
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Single- and multiple-dose pharmacokinetics of levovirin valinate hydrochloride (R1518) in healthy volunteers.

机译：盐酸左氧韦林缬氨酸盐酸盐（R1518）在健康志愿者中的单剂量和多剂量药代动力学。

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摘要

R1518 is a valine ester prodrug of levovirin as an investigational new drug for the treatment of hepatitis C virus. Two phase 1, single- and multiple-dose studies were conducted to investigate the pharmacokinetics of R1518 in healthy volunteers. After oral dosing, R1518 was rapidly and exclusively converted to levovirin. Levovirin plasma concentrations peaked at 2 hours, with T(1/2) ranging from 6 to 8 hours. The T(1/2) of R1518 was less than 1 hour, with relative exposures (R1518/levovirin) less than 6%. A high-fat meal did not affect the pharmacokinetics. The female groups in both studies had higher plasma levels than males did due to age and renal function difference. An accumulation ratio of 1.3 to 1.5 was observed with the twice-daily regimen. About 75% to 90% of the levovirin equivalent dose was recovered in urine. Increase in exposure was slightly disproportionate to increase in dose. Significantly improved oral absorption of levovirin was achieved following administration of R1518.
机译：R1518是左氧韦林的缬氨酸酯前药，是治疗丙型肝炎病毒的新药。进行了两个1期，单剂量和多剂量研究，以研究R1518在健康志愿者中的药代动力学。口服给药后，R1518迅速并完全转化为左氧韦林。 Levovirin血浆浓度在2小时达到峰值，T（1/2）范围为6至8小时。 R1518的T（1/2）小于1小时，相对暴露量（R1518 / levovirin）小于6％。高脂餐不影响药代动力学。由于年龄和肾功能的差异，两项研究中的女性血浆水平均高于男性。每天两次的方案观察到1.3至1.5的蓄积率。在尿液中回收了约百分之七十五至百分之九十的左氧韦林当量剂量。暴露增加与剂量增加不成比例。施用R1518后，左叶virin的口服吸收明显改善。

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