目的:评价健康志愿者同时口服磷酸瑞格列汀和缬沙坦的安全性和耐受性。方法:采用二阶段交叉试验设计,纳入18~45岁健康受试者16例,按照AB,BA给药序列随机分为2组,每个序列组8例,男女各半。各阶段间隔6 d洗脱期,第2阶段2个序列组交叉给药。观察生命体征、实验室检查指标、临床症状和不良事件等。结果:16例受试者全部完成试验。联用磷酸瑞格列汀片与缬沙坦胶囊后生命体征、实验室检查、心电图等均未出现有临床意义的异常变化。两药联用的不良事件主要为乳酸脱氢酶升高、感冒、腹泻、白细胞降低等,不良事件发生率为31.3%。这些事件的严重程度均为轻度,试验过程中未发生严重不良事件。结论:磷酸瑞格列汀与缬沙坦联用的安全性和耐受性良好。 PURPOSE: To evaluate the safety and tolerability of oral administration of reginalin and valsartan in healthy volunteers. Methods: A two-stage crossover trial was designed. Sixteen healthy subjects aged 18-45 years were enrolled in this study. They were randomly divided into two groups according to the sequence of AB and BA administration. Each sequence group consisted of 8 patients, half male and half female. Each stage of 6-day washout interval, the second phase of the two sequence groups cross-administered. Observation of vital signs, laboratory tests, clinical symptoms and adverse events. Results: All 16 subjects completed the experiment. In combination with repaglinide tablets and Valsartan capsules, there were no clinically significant abnormal changes in vital signs, laboratory tests and electrocardiograms. Adverse events associated with the two drugs are mainly elevated lactate dehydrogenase, cold, diarrhea, leukopenia, the incidence of adverse events was 31.3%. The severity of these incidents were mild and no serious adverse events occurred during the trial. Conclusions: The combination of valsartan and valproartine is safe and well tolerated.