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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 age and gender on the safety, tolerability, and pharmacokinetics of BAY 12-9566 in healthy subjects.
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Effect of age and gender on the safety, tolerability, and pharmacokinetics of BAY 12-9566 in healthy subjects.

机译：年龄和性别对健康受试者中BAY 12-9566的安全性，耐受性和药代动力学的影响。

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摘要

The impact of age and gender on the single-dose pharmacokinetics, safety, and tolerability of BAY 12-9566 was evaluated in healthy subjects. Volunteers were grouped according to age and gender (13 young males, 11 elderly males, and 12 elderly females) and then randomized in a 2:1 ratio to receive a single oral 50 mg dose of BAY 12-9566 or placebo. Serial plasma samples were collected up to 336 hours postdose and assayed for BAY 12-9566. Peak plasma concentration, time to reach peak plasma concentration, the area under the concentration-time curve, oral clearance, volume of distribution, and elimination half-life were calculated. BAY 12-9566 was well tolerated in all treatment groups, and no serious adverse events occurred during the study. Substantial age- or gender-related differences were not observed for any of the pharmacokinetic parameters tested. Based on these pharmacokinetic and tolerability profiles, age- or gender-related dose adjustments were not required for BAY 12-9566.
机译：在健康受试者中评估了年龄和性别对BAY 12-9566的单剂量药代动力学，安全性和耐受性的影响。根据年龄和性别将志愿者分组（13位年轻男性，11位老年男性和12位老年女性），然后以2：1的比例随机分配，以接受口服50毫克剂量的BAY 12-9566或安慰剂。给药后多达336小时收集系列血浆样品，并测定BAY 12-9566。计算峰值血浆浓度，达到峰值血浆浓度的时间，浓度-时间曲线下的面积，口腔清除率，分布体积和消除半衰期。 BAY 12-9566在所有治疗组中均具有良好的耐受性，并且在研究期间未发生严重的不良事件。对于所测试的任何药代动力学参数均未观察到明显的年龄或性别相关差异。基于这些药代动力学和耐受性特征，BAY 12-9566不需要调整年龄或性别相关的剂量。

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