摘要
目的：观察健康受试者对舒尔痛分散片单次给药剂量的耐受性和安全性，为多次给药及Ⅱ期临床试验推荐安全剂量。方法：单次给药试验中30例受试者随机分为6个剂量组，分别给予舒尔痛分散片0．44，0．88，1．32，2．2，3．08和3．52g。观察受试者的临床症状、生命体征、实验室检查、心电图检查及不良事件等。结果：30例受试者全部完成耐受性试验，单次给药剂量下所有受试者未见重要生命体征有明显改变，无不良事件发生。结论：舒尔痛分散片在0．44～3．52g剂量范围内单次给药安全性和耐受性良好，最大耐受剂量为3．52g，推荐多次给药剂量为2．2g·d^-1。
Objective： To observe the tolerance and safety of healthy subjects to Shuertong dispersible tab- let, and to recommend the safe dosage for continuous medication trial and phase Ⅱ clinical trial. Methods： Thirty healthy volunteers attended the single dose trial. They received 6 doses （0.44, 0.88, 1.32, 2.2, 3.08 and 3.52 g） randomly. The safety was evaluated based on clinical symptoms, vital signs, laboratory tests, ECG and adverse e- vents. Results： All the 30 healthy volunteers completed the tolerance test. Significant changes in vital signs, AE and SAE were not observed in all subjects in single dose trials. Conclusion： Shuertong dispersible tablet is well tolerated and safe in healthy volunteers. The maximal tolerance dosage is 3.52 g daily. The dose regimen of 2.2 g. d^-1 is recommended for continuous medication trials.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2014年第9期1063-1065,共3页
Chinese Journal of New Drugs
关键词
舒尔痛分散片
I期临床试验
安全性
耐受性
Shuertong dispersible tablet
phase Ⅰ clinical trial
safety
tolerance
