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注射用丹酚酸B在中国健康成人受试者的单次与多次用药安全性及耐受性的I期临床研究
[Translation] Phase I clinical study on the safety and tolerability of single and multiple doses of salvianolic acid B for injection in healthy Chinese adult subjects
1. 主要目的: 评价注射用丹酚酸B单次与多次用于中国健康成人受试者的安全性及耐受性。 2. 次要目的,探索注射用丹酚酸B: (1)皮肤试验方法。 (2)单次与多次用于中国健康成人受试者的药代动力学特征。 (3)单次与多次用于中国健康成人受试者的药效学特征。 (4)单次用于中国健康成人受试者的经肾排泄特征。
[Translation] 1. Primary objective: To evaluate the safety and tolerability of single and multiple administrations of salvianolic acid B for injection in healthy Chinese adult subjects. 2. Secondary objectives: To explore the following aspects: (1) Skin test methods. (2) Pharmacokinetic characteristics of single and multiple administrations in healthy Chinese adult subjects. (3) Pharmacodynamic characteristics of single and multiple administrations in healthy Chinese adult subjects. (4) Renal excretion characteristics of single administration in healthy Chinese adult subjects.
100 Clinical Results associated with Nanjing Xianhui Pharmaceutical Engineering Research Institute Co., Ltd.
0 Patents (Medical) associated with Nanjing Xianhui Pharmaceutical Engineering Research Institute Co., Ltd.
100 Deals associated with Nanjing Xianhui Pharmaceutical Engineering Research Institute Co., Ltd.
100 Translational Medicine associated with Nanjing Xianhui Pharmaceutical Engineering Research Institute Co., Ltd.