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莫索尼定与格列本脲可能的药代动力学相互作用的稳态研究。

Steady state investigation of possible pharmacokinetic interactions of moxonidine and glibenclamide.

作者信息

Müller M, Weimann H J, Eden G, Weber W, Michaelis K, Dilger C, Achtert G

机构信息

L.A.B. GmbH & Co, Neu-Ulm, Germany.

出版信息

Eur J Drug Metab Pharmacokinet. 1993 Jul-Sep;18(3):277-83. doi: 10.1007/BF03188809.

Abstract

The aim of the study presented here was to determine possible pharmacokinetic interactions of moxonidine and glibenclamide at steady state in 18 healthy male volunteers. Multiple oral doses of 0.2 mg of moxonidine b.i.d. (q. 12 h) and of 2.5 mg of glibenclamide o.i.d. (q. 24 h) were administered alone and in combination in an open, non-randomized, three-treatment design. The preparations were given for 5 days in each of the 3 periods. The results of this multiple dose study did not indicate substantial pharmacokinetic interactions of the drugs. Regarding the influence of glibenclamide on the pharmacokinetics of moxonidine, no significant changes were seen at all. In the presence of moxonidine, a minor decrease of bioavailability of glibenclamide was detectable, as could be derived from the AUC and clearance data. The actual differences were small and not considered to be of clinical significance.

摘要

本研究的目的是确定18名健康男性志愿者在稳态下莫索尼定和格列本脲之间可能存在的药代动力学相互作用。在一项开放、非随机的三治疗组设计中,分别单独及联合给予多次口服剂量的0.2 mg莫索尼定,每日两次(每12小时一次)和2.5 mg格列本脲,每日一次(每24小时一次)。在3个周期的每个周期中,这些制剂均给药5天。这项多剂量研究的结果并未表明这些药物之间存在显著的药代动力学相互作用。关于格列本脲对莫索尼定药代动力学的影响,未观察到任何显著变化。在存在莫索尼定的情况下,从AUC和清除率数据可以看出,格列本脲的生物利用度有轻微下降。实际差异很小,不被认为具有临床意义。

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