Tolerability research of single dose of iptakalim hydrochloride in healthy Chinese volunteers

AIM: To evaluate the safety and tolerability of single dose of iptakalim hydrochloride in healthy Chinese volunteers.METHODS: 52 healthy volunteers in 18-50 years old were chosen and randomized into 6 dose groups,including 2.5,5,10,15,20,25 mg.Group B,C,D,E contained 10 volunteers respectively,and Group A and F contained 6 volunteers.Each group contained 2 volunteers(1 male and 1 female) who were administrated with placebo.Clinical symptoms,vital signs,the changes of laboratory examination indexes,and all adverse drug events were observed.RESULTS: After single dose of 2.5-25 mg,the clinical symptoms,vital signs and index of laboratory examination were in normal range.There were no severe adverse events,and no adverse events were related to the drug.CONCLUSION: The single-dose of iptakalim hydrochloride range from 2.5 mg to 25 mg in healthy Chinese volunteers were safe and tolerable in 52 healthy Chinese volunteers.