单次口服伐地那非片在健康志愿者的耐受性

Toleration of vardenafil tablets in healthy volunteers after a single oral administration

目的 观察伐地那非对中国健康男性志愿者的耐受性。方法 用随机、双盲、安慰剂对照、剂量递增试验设计,48名入选者,单次口服5,10,20和40 mg伐地那非分别对比给药前后及各剂量组间受试者的临床症状和实验室化验结果。结果 服药前后,受试者的体征没有显著性变化,组间受试者的体征没有明显差异,试验室检查结果中个别指标虽有统计学意义,但均在正常范围内,无临床意义。结论 受试者对伐地那非5～40 mg的应用剂量具有很好的耐受性,临床推荐1 0～20mg单次服用剂量。

Objective To observe the tolerance of vardenafil in Chinese healthy male volunteers. Methods Fourty-eight volunteers were enrolled in the single-dose randomized, double-blinded, placebo-controlled, dose-escalation trial. Comparisons were made on the clinical symptoms and laboratory examinations acquired pre-dosing and after dosing, respectively. Comparisons were made among different dose groups, too. Results No singnificant statistical difference in physical sign were detected after a single oral vardenafil dose of 5,10,20 and 40 mg between trial and control, before and after treatment, respectively. There were no statistical significant difference in the laboratory examinations after dosing. There were no statistical significant difference in the laboratory examinations between different doses. Although there were some statistical changes in the laboratory examinations, the results are in the normal range. Conclusion The results suggested that the tolerance of vardenafil between 5~40mg is good, and 10 to 20mg of vardenafil at a time recommended for clinical use is acceptable.