Safety and pharmacokinetics of ioversol in healthy volunteers.
Ioversol 320, a new nonionic iodinated contrast medium, was injected intravenously into 24 healthy male volunteers using saline as a control. Physical examination, vital signs, electrocardiogram, biochemical and hematological data were recorded before and at intervals after injection. No significant changes were observed. Seventeen volunteers reported no side effects; six volunteers had mild transitory symptoms considered to be related to the contrast medium. The authors conclude that broader clinical trials can be safely conducted to determine safety and tolerability of ioversol.
Wilkins
R A
RA
Radiology Department, Northwick Park Hospital, Harrow, Middlesex, England.
Whittington
J R
JR
Brigden
G S
GS
Lahiri
A
A
Heber
M E
ME
Hughes
L O
LO
D000328:Adult; D001774:Blood Chemical Analysis; D001794:Blood Pressure / Q000187:drug effects; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology*; D004341:Drug Evaluation; D004562:Electrocardiography / Q000187:drug effects; D006801:Humans; D007463:Iodobenzoates / Q000494:pharmacology*; D008297:Male; D011897:Random Allocation; D012449:Safety; D016037:Single-Blind Method; D014283:Triiodobenzoic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology*
D003287:Contrast Media; D007463:Iodobenzoates; D014283:Triiodobenzoic Acids; C054871:ioversol