Tolerability of Baicalein Chewable Tablets in Chinese Healthy Volunteers: A Single-dose Dose-escalating Study
XUE Wei 1, SHI Ai-xin1*, LI Min1, DONG Fan1, LI Yang1, YAN Bei1, XIAO Wei2, DU Guan-hua3, HU Xin1
1. Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation, Department of Pharmacy, Beijing Hospital, Beijing 100730, China; 2.State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Jiangsu Kanion Parmaceutical CO.LTD, Lianyungang 222001, China; 3. Beijing Key Laboratory of Drug Targets Identification and Drug Screening, Institute of Materia Medica, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100050, China
Abstract��OBJECTIVE To evaluate the safety and tolerability of baicalein chewable tablets and establish the maximum tolerated dose in healthy volunteers. METHODS A randomized, double-blind, dose-escalating, single-center, phase I clinical trial was conducted in 70 healthy male and female subjects. Each subject received oral baicalein only once. Adverse events were identified either by subject self-reporting or evaluation based upon vital signs, physical examination and laboratory parameters. The study was conducted from low to high dose, and the dose escalation was performed only after the safety and tolerability were confirmed favorable. RESULTS Baicalein chewable tablets were well tolerated and had an acceptable safety profile up to the highest dose of 2 800 mg. The vital signs of all subjects were stable, and no QTc interval prolongation was observed during the trial. A total of 11 mild adverse events were reported in 8 subjects. There were no severe adverse events in the study, and none of the adverse events led to withdrawal. CONCLUSION This study suggests that the innovative drug baicalein chewable tablets are well tolerated in healthy Chinese volunteers within the dose range of 100 to 2 800 mg.
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XUE Wei , SHI Ai-xin, LI Min, DONG Fan, LI Yang, YAN Bei, XIAO Wei, DU Guan-hua, HU Xin. Tolerability of Baicalein Chewable Tablets in Chinese Healthy Volunteers: A Single-dose Dose-escalating Study. Chinese Pharmaceutical Journal, 2015, 50(22): 1987-1991.
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2015, Vol. 50 
