Nürnberger H, Stade K
Pharmazie. 1985 Dec;40(12):871-3.
To ensure toxicologically the potential antiarrhythmic agent 3-carbethoxyamino-5-dimethylamino-acetyl-10,11-dihydro-dibenz[b,f] azepine hydrochloride (Bonnecor, GS 015, AWD 19-166), the following preclinical studies have been made up to the present: Determination of the acute toxicity on mice and rats, toxicity test on the rat by repeated applications, study as to the action of GS 015 on the prenatal development of the rat, diverse toxicologic studies on reproduction, mutagenity tests by using the DNA repair test and the Ames test. The results of these studies are represented in a summarized form. A good tolerance of GS 015 can be derived from the results of the preclinical studies gained up to now.
为从毒理学角度确保潜在的抗心律失常药物盐酸3-乙氧羰基氨基-5-二甲氨基乙酰基-10,11-二氢二苯并[b,f]氮杂卓(邦尼可,GS 015,AWD 19 - 166)的安全性,截至目前已开展了以下临床前研究:测定对小鼠和大鼠的急性毒性、大鼠重复给药毒性试验、GS 015对大鼠产前发育作用的研究、各种生殖毒性研究、利用DNA修复试验和艾姆斯试验进行的致突变性试验。这些研究结果以总结形式呈现。从目前所获临床前研究结果可得出GS 015具有良好耐受性。