Clinical tolerability of 1, 5-dicaffeoylquinic acid tablets
WEI Zhen-man
DING Jin-biao
HU Lin
CHEN Hong-ge
WU Rong-rong
HE Jiang-ping
ZHANG Yue-mei
DONG Jun-xing
Abstract：Objective:To evaluate the safety and tolerability of 1,5-dicaffeoylquinic acid tablets in Chinese healthy volunteers. Methods:The protocol was designed according to the Good Clinical Practice(GCP). Fifty-eight healthy volunteers were randomly divided into 7 dosage groups treated with 50,200,400,600,800,1 000 and 1 200 mg, respectively. Thirty healthy volunteers were randomly divided into 3 dosage groups treated with 200,300,500 mg twice daily. There are 2 ～ 5 males and 2 -5 females in each group. Clinical symptoms, vital signs, and laboratory tests were observed before and after 1,5-dicaffeoylquinic acid tablets administration to evaluate the adverse events. Results: Most vital signs, clinical symptoms and laboratory tests were normal in the volunteers with single dose and multiple doses of 1,5-dicaffeoylquinic acid tablets. Only 9 cases of slight and tolerable adverse drug reactions were observed. Conclusion:Single-dose regimen up to 1 200 mg and multiple dose regimen up to 500 mg, twice daily of 1,5-dicaffeoylquinic acid tablets are safe and tolerable.
Keywords：15-dicaffeoylquinic acid tabletstolerabilityphase I clinical trial
Publication Date：2010-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：3( 106-108 )