Abstract: 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. 5-25mg, 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.

Key words: iptakalim hydrochloride, safety, tolerability