[Iodixanol. A new isotonic x-ray contrast medium].
In this phase I study, safety, tolerance and pharmacokinetics of iodixanol 300 mg I/ml, were evaluated in 40 healthy male volunteers using four dose levels. No clinically important influences on renal function parameters, hemodynamics, ECG or clinical-chemical parameters in blood and urine were observed. 17 adverse events including discomfort were reported, but only three of them (sensation of warmth) were classified as related to iodixanol. CT-investigations revealed a dose-related, reversible increase in kidney cortex density. However, iodixanol caused no changes in glomerular function, and the increase in excretion of tubular enzymes was less than caused by other nonionic x-ray contrast media. Further investigations will focus on the safety and efficacy of iodixanol in patients.
Nossen
J O
JO
Nycomed AS, Oslo.
Andrew
E
E
Aakhus
T
T
Berg
K J
KJ
Jørgensen
N P
NP
D000328:Adult; D003287:Contrast Media / Q000009:adverse effects / Q000737:chemistry / Q000493:pharmacokinetics; D004341:Drug Evaluation; D006801:Humans; D008297:Male; D014283:Triiodobenzoic Acids / Q000737:chemistry / Q000493:pharmacokinetics
D003287:Contrast Media; D014283:Triiodobenzoic Acids; C044834:iodixanol