Bender W, Greil W, Rüther E, Schnelle K
J Clin Pharmacol. 1979 Aug-Sep;19(8-9 Pt 2):505-12. doi: 10.1002/j.1552-4604.1979.tb02515.x.
Sotalol (Sotalex), 320 or 960 mg, was administered to 12 healthy subjects daily for a period of four days in a double-blind trial over 11 days. The effects of sotalol on heart rate, blood pressure, EEG, subjective quality of sleep, polygraphically determined sleep pattern, and psychophysiological parameters such as psychomotor performance, memory, perception, vigilance, and general condition were studied and were related to dosage and plasma levels. Steady-state plasma levels of sotalol were reached within 24 hours after a single dose; 960 mg resulted in plasma levels three times higher than those reached with 320 mg, which indicates first-order linear absorption. The effects of sotalol on EEG, sleep, and performance in psychological tests were equivocal and do not yield evidence for CNS activity of sotalol.
在一项为期11天的双盲试验中,12名健康受试者每天服用320毫克或960毫克索他洛尔(苏他来克斯),持续4天。研究了索他洛尔对心率、血压、脑电图、主观睡眠质量、多导睡眠图测定的睡眠模式以及心理生理参数(如精神运动表现、记忆、感知、警觉性和一般状况)的影响,并将其与剂量和血浆水平相关联。单次给药后24小时内达到索他洛尔的稳态血浆水平;960毫克导致的血浆水平比320毫克时高出三倍,这表明存在一级线性吸收。索他洛尔对脑电图、睡眠和心理测试表现的影响不明确,无法提供索他洛尔具有中枢神经系统活性的证据。