Michos N, Zulliger H W, Möller T, Klein G
Arzneimittelforschung. 1986 Jun;36(6):949-54.
To 12 healthy male volunteers, who had given their consent, 11 administrations of alpha-methyl-4-(2-thienyl-carbonyl)phenylacetic acid (suprofen, Suprol) sustained release tablets 600 mg were given twice a day with a dosage interval of 12 h. It could be demonstrated that suprofen given as multiple dose application of sustained release tablets was well tolerated. Effective mean plasma levels were reached after the second dosage. There was no indication of accumulation nor accelerated elimination during the 6-day period. There was no statistically significant difference between the mean plasma curve after the last administration of the 6-day period and the mean plasma curve after the 3rd application. Also the AUC's in the respective intervals turned out not to be statistically significantly different from each other. Clinical and laboratory tests showed no clinically relevant deviations from the normal range. No adverse reactions whatsoever were observed.
对12名已签署知情同意书的健康男性志愿者,每天两次给予11剂600毫克α-甲基-4-(2-噻吩基羰基)苯乙酸(舒洛芬,Suprol)缓释片,给药间隔为12小时。结果表明,多次服用舒洛芬缓释片耐受性良好。第二次给药后达到有效的平均血浆水平。在6天期间未显示有蓄积现象,也未出现消除加速。在6天期间最后一次给药后的平均血浆曲线与第三次给药后的平均血浆曲线之间无统计学显著差异。各个时间段的AUC彼此之间也无统计学显著差异。临床和实验室检查未显示与正常范围有临床相关偏差。未观察到任何不良反应。