The first iopentol study in human beings (phase 1)

The pharmacologic effects of intravenous injections of iopentol (Nycomed AS, Oslo, Norway) in 24 healthy male volunteers were studied. Doses from 300 to 1200 mg I/kg b.w. were well tolerated. Some persons had a slight heat sensation, abnormal abdominal sensations, thirst, or nausea. Headache was reported in a few subjects both after iopentol and saline injections, and was considered to be procedure related. No severe events occurred. Minor changes were observed in some biochemical and physiological parameters, but were usually within normal ranges and without clinical importance. Some of these effects also occurred in the control group after saline injections. Iopentol was excreted mainly in the urine and no metabolites were detected. The results indicated that clinical trials with iopentol could be undertaken. (author). 7 refs.; 2 tabs