Safety assessment of gadoversetamide (OptiMARK) administered by power injector.
OBJECTIVE
To evaluate the safety of OptiMARK (gadoversetamide injection) administered via power injector.


METHODS
The study population included 144 healthy volunteers aged 18 years or older randomly assigned to one of seven treatment groups (N = 20/group). The safety assessment was based on changes in physical examination, vital signs, electrocardiograms (ECGs), standard clinical laboratory tests, and adverse events (AEs) through a 24-hour postinjection period.


RESULTS
OptiMARK caused no serious AEs or unexpected changes in physical examinations or laboratory parameters. The changes observed in vital signs and ECG intervals did not vary with changes in injection rate and were not significantly (P < 0.05) different from those elicited by saline administration at the same rates.


CONCLUSIONS
This study demonstrated the safety of OptiMARK when administered via a power injector at rates of 2, 4, and 6 mL/second.
Abdou
Nancy
N
Quintiles Phase 1 Services, Lenexa, Kansas, USA.
Napoli
Alicia M
AM
Hynes
Michael R
MR
Allen
John C
JC
Wible
James H
JH
D000704:Analysis of Variance; D003287:Contrast Media / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D007275:Injections, Intravenous / Q000379:methods; D008279:Magnetic Resonance Imaging; D008297:Male; D009942:Organometallic Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D016012:Poisson Distribution; D012449:Safety
D003287:Contrast Media; D009942:Organometallic Compounds; C112666:gadoversetamide