脑清智明片在中国健康受试者中的单中心、随机、双盲、安慰剂对照、剂量递增的Ⅰ期临床研究
[Translation] A single-center, randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study of Naoqingzhiming tablets in healthy Chinese subjects
(1)评估中国健康受试者单次、多次口服脑清智明片的安全性和耐受性,确定最大耐受剂量(MTD),为II期临床试验推荐合适的给药剂量(RP2D)。 (2)考察脑清智明片单次、多次给药后在中国健康受试者体内的药代动力学(PK)特征。
[Translation] (1) To evaluate the safety and tolerability of single and multiple oral administration of Naoqingzhiming tablets in healthy Chinese subjects, determine the maximum tolerated dose (MTD), and recommend an appropriate dosing dose (RP2D) for Phase II clinical trials. (2) To investigate the pharmacokinetic (PK) characteristics of Naoqingzhiming tablets in healthy Chinese subjects after single and multiple administration.
100 Clinical Results associated with Beijing Rainforest Medical Technology Co., Ltd.
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100 Translational Medicine associated with Beijing Rainforest Medical Technology Co., Ltd.