Kopera H, Schenk H, Voerman J W
Int J Clin Pharmacol Biopharm. 1978 Nov;16(11):529-32.
The effect of a 14 day treatment with Org GC 94 in rising dosage to a maximum of 45 mg/day on thrombocyte function, blood coagulation and the fibrinolytic system was investigated in 16 healthy volunteers in a double-blind comparative trial with placebo. At the same time the influence on some liver function tests and on the general condition of the subjects was followed. Analysis of the data obtained in tests pertaining to platelet function, blood coagulation, fibrinolysis and liver function did not indicate unwanted or harmful effects of Org GC 94. No significant difference in effect between Org GC 94 and placebo was detectable. The general physical condition including appetite and body weight was not affected by Org GC 94. A mild, transient sedative effect of the maximum dose of Org GC 94 is likely and some influence upon concentration (decrease) and mood (indifference or elevation) in some subjects cannot be excluded.
在一项针对16名健康志愿者的双盲安慰剂对照试验中,研究了以递增剂量(最大剂量为45毫克/天)进行14天的Org GC 94治疗对血小板功能、血液凝固和纤维蛋白溶解系统的影响。同时,观察了其对一些肝功能测试及受试者一般状况的影响。对血小板功能、血液凝固、纤维蛋白溶解和肝功能测试所获数据的分析表明,Org GC 94未产生不良或有害影响。未检测到Org GC 94与安慰剂在疗效上的显著差异。Org GC 94未影响包括食欲和体重在内的一般身体状况。Org GC 94最大剂量可能有轻微、短暂的镇静作用,并且不能排除对某些受试者的注意力(下降)和情绪(冷漠或高涨)有一定影响。