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Human pharmacokinetics of iodixanol
M G Svaland1, T Haider, K Langseth-Manrique
1Department of Bioanalysis, Nycomed AS, Oslo, Norway.
Investigative Radiology
|February 1, 1992
Summary
This study investigated iodinated contrast media pharmacokinetics in healthy volunteers. Iodixanol demonstrated predictable excretion, primarily via glomerular filtration, supporting its safety profile for X-ray imaging.
Area of Science:
- Pharmacology
- Radiology
- Nephrology
Background:
- X-ray contrast media are essential for medical imaging.
- Understanding the pharmacokinetic properties of new contrast agents is crucial for safety and efficacy.
- Iodixanol is a novel nonionic dimer contrast agent.
Purpose of the Study:
- To evaluate the pharmacokinetic properties of iodixanol in healthy male volunteers.
- To determine the absorption, distribution, metabolism, and excretion (ADME) profile of iodixanol.
- To assess the impact of different intravenous doses on iodixanol pharmacokinetics.
Main Methods:
- Phase I clinical study involving 40 healthy male volunteers.
- Intravenous administration of iodixanol at doses of 0.3, 0.6, 0.9, and 1.2 g iodine/kg body weight.
- Concomitant administration of 51Cr-EDTA to assess renal excretion via glomerular filtration.
Main Results:
- Mean half-lives for iodixanol were 26 minutes (distribution phase) and 131 minutes (elimination phase).
- Apparent volume of distribution was 0.28 L/kg, indicating distribution limited to extracellular fluid.
- Approximately 97% of the administered dose was excreted unchanged in urine within 24 hours, with 1.2% in feces.
- Pharmacokinetic parameters were dose-independent.
Conclusions:
- Iodixanol exhibits predictable pharmacokinetics characterized by rapid distribution and elimination primarily through glomerular filtration.
- The excretion profile of iodixanol is comparable to other intravascular contrast media.
- These findings support the safety and suitability of iodixanol for diagnostic imaging procedures.