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本文旨在评价国产伊拉地平胶囊在中国健康受试者体内的耐受性和安全性。单次给药的剂量递增顺序依次为2.5 mg,5 mg,10 mg。其中5 mg剂量组的受试者在完成单次给药试验后需继续留在研究中心,进行多次给药试验。医学观察指标包括生命体征、心电图、水肿及医学实验室检查。结果显示单次给药各组受试者的血压在服药后均有下降趋势。不良事件主要包括头痛、面部潮红、皮肤瘙痒和转氨酶升高。因此,按照试验设计的给药剂量和方案,受试者对伊拉地平有较好的耐受性。
The purpose of this article is to evaluate the tolerability and safety of homemade ilabedipine capsules in healthy Chinese subjects. The dose of single dose was in the order of 2.5 mg, 5 mg, 10 mg. Subjects in the 5-mg dose group were required to remain in the research center after completing a single-dose study and were tested for multiple doses. Medical observation indicators include vital signs, electrocardiogram, edema and medical laboratory tests. The results showed a single administration of each group of subjects in the blood pressure after taking a downward trend. Adverse events mainly include headache, facial flushing, itchy skin and elevated transaminases. Therefore, subjects were well tolerated with ripradine according to the dose and schedule of the test design.