Based on top line data, the trial achieved the primary endpoint demonstrating pharmacokinetic bioequivalence between CE-Iohexol injection and a reference Iohexol injection, or Omnipaque
, after intravenous, or IV, administration in healthy adults.
After acquiring anteroposterior and mediolateral scout views, 1.5 mL/kg of IV contrast agent was administered (Omnipaque
[300 mg I/mL], GE Healthcare) at a rate of 3 mL/s followed by 20 mL of 0.9% NaCl at the same injection rate.
Data were acquired before and after administration of iodinated contrast material (2 mL/kg IV; iohexol 300 mg/mL; Omnipaque
, GE Healthcare, Marlborough, MA, USA).
Non-Ionic Contrast media (OMNIPAQUE
350) was used and the flow rate was adjusted to 4 ml/s by an injection pump for every 1.5 ml/Kg of body weight.
The trial design consists of a single-centre, randomised, double-blind, two-period crossover study to determine relative bioavailability of CE-Iohexol and a reference Iohexol injection (OMNIPAQUE
) after IV administration in a population of 24 healthy adults (ClinicalTrials.gov identifier: NCT03869983).
anthracis Ames (pXO1+/pXO2+), Sterne, and ANR (pXO1+/pXO2-) in Leighton and Doi broth (19) or on NBY agar plates (20) and purified them with Omnipaque
(GE Healthcare, https://www.gehealthcare.com) as previously described (21).
The CCTA was acquired with ECG gated retrospective in a 256 slice iCT (Philips) following IV 60 cc of Omnipaque
370 at 5.0 cc/sec.
lohexol * Omnipaque
lopamidol * lsovue-370 lopromide * Ultravist Ioxilan * Oxilan
Contrast-enhanced helical CT scans (collimation, 4x2.5 mm; slice thickness, 5 mm; range of reconstruction, 5 mm; section 64, Aquilion; Toshiba Medical Systems, Tokyo) were obtained 65 s after the administration of 100 mL Iohexol (Omnipaque
300) at a rate of 3 mL/s.
(Iohexol 350mg I/ml) X-ray contrast agent was administered to all patients.
Once when the position was confirmed, 1 ml of non-ionic contrast agent (Iohexol, omnipaque
350 mgl m[L.sup.-1]) was injected, and a fluoroscopic image was obtained to assess the spread of the dye (Figure 3).
The CT scan was performed using 64-slice CT scanner (Aquilion 64; Toshiba Medical Systems Corporation, Otawara, Japan) in the portal venous phase after intravenous gadolinium contrast administration (Omnipaque
350; Nycomed Amersham, Princeton, NJ, USA).