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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >The pharmacokinetics, pharmacodynamics, and tolerability of liraglutide, a once-daily human GLP-1 analogue, after multiple subcutaneous administration in healthy Chinese male subjects.
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The pharmacokinetics, pharmacodynamics, and tolerability of liraglutide, a once-daily human GLP-1 analogue, after multiple subcutaneous administration in healthy Chinese male subjects.

机译：利拉鲁肽（一种每天一次的人类GLP-1类似物）在健康的中国男性受试者中多次皮下给药后的药代动力学，药效学和耐受性。

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摘要

In this single-center, randomized, double-blind, within dose group, placebo-controlled, dose escalation trial, the pharmacokinetics, pharmacodynamics, tolerability, and safety of liraglutide were evaluated in 37 healthy Chinese subjects. Subjects were randomized to 1 of 3 dose groups (0.6, 1.2, or 1.8 mg), and within each group, randomized to liraglutide or placebo (3:1). All subjects started at 0.6 mg liraglutide (or placebo) once daily for 1 week, and the dose was increased for dose groups 1.2 mg and 1.8 mg in weekly steps of 0.6 mg to the predefined dose targets. Liraglutide or placebo was administered once daily by subcutaneous injection for 21 consecutive days. The dose relationships of AUC(0-24h), C(max), and C(trough) at steady state do not deviate in a relevant way from dose proportionality. t(max) and t(1/2) were 8 hours (median) and 11.2 to 12.2 hours (geometric mean), respectively. The plasma glucose levels in all liraglutide groups were decreased, while reduced serum insulin level was observed in the 1.2- and 1.8-mg groups after liraglutide treatment. The most common adverse events were of gastrointestinal origin. Other adverse events were comparable between the liraglutide and placebo groups. Liraglutide was well tolerated in healthy Chinese subjects. No major safety concerns were identified.
机译：在这个单中心，随机，双盲，剂量组内，安慰剂对照的剂量递增试验中，对37名健康的中国受试者进行了利拉鲁肽的药代动力学，药效学，耐受性和安全性评估。将受试者随机分为3个剂量组（0.6、1.2或1.8 mg）中的1个，在每个组中，随机分为利拉鲁肽或安慰剂（3：1）。所有受试者每天从0.6 mg利拉鲁肽（或安慰剂）开始，持续1周，然后以0.6 mg的每周剂量将0.6 mg和1.8 mg剂量组的剂量增加至预定剂量目标。利拉鲁肽或安慰剂通过皮下注射每天一次，连续21天。稳态下的AUC（0-24h），C（max）和C（谷）的剂量关系不会以相关方式偏离剂量比例。 t（max）和t（1/2）分别为8小时（中位数）和11.2至12.2小时（几何平均值）。利拉鲁肽治疗后，所有利拉鲁肽组的血浆葡萄糖水平均降低，而在1.2mg和1.8mg组中观察到血清胰岛素水平降低。最常见的不良事件是胃肠道起源的。利拉鲁肽组与安慰剂组之间的其他不良事件相当。利拉鲁肽在健康的中国受试者中具有良好的耐受性。没有发现重大安全隐患。

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