Objective To evaluate the safety and tolerance of medicinal charcoal enteric-coated tablets in healthy volunteers.
Methods A total of 44 healthy volunteers were randomly divided into 6 single-dose groups (0.5 g, 2 g, 4 g, 6 g, 8 g and 10 g) and a multiple-dose group (3 g, 3 times a day, for 14 days). The safety profile and tolerance were evaluated by observing symptoms, vital signs, and laboratory tests.
Results No serious adverse event was reported for any volunteer. Abdominal distension occurred in 2 volunteers in the 4 g dose group and the 6 g dose group. One volunteer in the 8 g dose group experienced nausea and vomiting. Transient decrease in white blood cell count was observed in one volunteer in the 10 g dose group. Abdominal distension occurred in 2 volunteers of the multiple-dose group.
Conclusion Based on our findings, the maximum tolerated dose of medicinal charcoal enteric-coated tablets in Chinese healthy volunteers is 10 g. The recommended dose for subsequent clinical trials is 3 g, 3 times a day.
Citation： WU Songze,MIAO Jia,LUO Zhu,WANG Ying. Tolerance of Medicinal Charcoal Enteric-coated Tablets in a Phase I Study. Chinese Journal of Evidence-Based Medicine, 2009, 09(2): 204-206. doi: 10.7507/1672-2531.20090041 Copy