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目的:评价健康受试者对泰利心胶囊的耐受性和安全性,为Ⅱ期临床试验给药方案提供依据。方法:选择健康受试者44例,随机进入7个单次给药组和2个连续给药组。单次给药组分别口服泰利心胶囊100mg、200mg、300mg、500mg、700mg、900mg、1200mg,连续给药组口服泰利心胶囊1次200mg和300mg,1天2次,服药7天。观察生命体征、实验室检查指标、临床症状和不良反应。结果:单次给药无不良反应,连续给药剂量组有轻微头痛的不良反应。结论:健康人体对泰利心胶囊耐受性较好,临床应用较安全,仅见轻微头痛。推荐Ⅱ期临床试验给药剂量范围是1次100mg～200mg,1天2次。
Objective: To evaluate the tolerance and safety of Teliculose Capsule in healthy subjects and to provide evidence for the dosing schedule of Phase Ⅱ clinical trial. Methods: Forty-four healthy subjects were selected and randomized into seven single-dose and two continuous-dose groups. The single administration group was orally given teltazole capsule 100mg, 200mg, 300mg, 500mg, 700mg, 900mg, 1200mg, continuous administration group oral Teliculose capsules 200mg and 300mg twice a day for 7 days. Observation of vital signs, laboratory tests, clinical symptoms and adverse reactions. Results: There were no adverse reactions in single administration and continuous adverse reactions with slight headache in continuous dose group. Conclusion: The healthy human body is well tolerated by Teli Heart Capsule, and its clinical application is safer with only mild headache. The recommended phase Ⅱ clinical trial dose range of 100mg ~ 200mg once a day, twice a day.