关键词: 埃本膦酸钠, 耐受性, 健康志愿者

Abstract: AIM: To evaluate the safety and toler-ance of ibandronate in Chinese healthy volunteers. METHODS: The trial protocol wasdesigned according to the Good Clinical Practice(GCP). After physical exami-nation and laboratory tests were performed, 36 healthy volunteers were divided randomly into 6 dose groups, in-cluding 1 mg, 2 mg, 3 mg, 4 mg, 5 mg and 6 mg, with 6 subjects in each group(3 male and 3 female). Clinical symptoms, vital signs, routine blood tests, routine urine tests, hepatic function, renal function, blood elec-trolytes, electrocardiogram, and electroencephalogram were observed or examined before and after a single intra-venous infusion of ibandronate.RESULTS: After single intravenous infusion doses of 1 -6 mg, the vital signs, clinical symptoms and laboratory testswere all in the nor-mal range, but there were some slight ADRs concerned with the drug, such as hypophosphataemia, increased body temperature, perspiring, pain of bone or muscle and hypocalcaemia. But the ADRs were found vanishing in one or two weeks.CONCLUSION: Single intravenous infusion (up to 6 mg) of domestic ibandronate in 36 chi-nese healthy volunteers is safe and tolerable.

Key words: ibandronate, tolerance, healthy volun-Teers