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[Translation] Phase I clinical tolerability trial of Mianwu oil soft capsules
本研究采用剂量递增方案,对健康志愿者进行不同剂量单次给药,以考察人体对单次服用蘼芜油软胶囊的耐受性,确定人体安全、耐受剂量;再根据单剂量耐受性试验结果进行拟推荐临床用药方案的多次给药耐受性试验,以完成该药初步的人体安全性评价,为制定II期临床试验给药方案提供依据。
[Translation] This study adopted a dose escalation scheme and administered different single doses to healthy volunteers to examine the human body's tolerance to a single dose of Miwu Oil Soft Capsules and determine the human body's safe and tolerable dose. Based on the results of the single-dose tolerance test, a multiple-dose tolerance test of the proposed clinical medication regimen was conducted to complete the preliminary human safety evaluation of the drug and provide a basis for formulating the dosing regimen for the Phase II clinical trial.
100 Clinical Results associated with Chengdu High-tech Zone Kaiyuan Pharmaceutical Co., Ltd.
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