Investigation on the tolerance of ibandronate by a single intravenous infusion / 中国临床药理学与治疗学

ABSTRACT

AIM: To evaluate the safety and tolerance of ibandronate in Chinese healthy volunteers. METHODS: The trial protocol was designed according to the Good Clinical Practice(GCP). After physical examination and laboratory tests were performed, 36 healthy volunteers were divided randomly into 6 dose groups, including 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 electrolytes, electrocardiogram, and electroencephalogram were observed or examined before and after a single intravenous infusion of ibandronate. RESULTS: After single intravenous infusion doses of 1- 6 mg , the vital signs, clinical symptoms and laboratory tests were all in the normal 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 chinese healthy volunteers is safe and tolerable.