Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01672996 | Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Abdominal CECT in Healthy Volunteers | PHASE1 | COMPLETED | 66 | — | — | Jul 1, 2012 | Aug 1, 2012 | May 29, 2014 | 1 | United States |
Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.
Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.
| Arm | Type | Description |
|---|---|---|
| Arm 1 - Ioforminol 160mgI/mL | EXPERIMENTAL | Single administration of Ioforminol 160mgI/mL given to the subject. |
| Arm 2 - Ioforminol 200mgI/mL | EXPERIMENTAL | Given as a single administration to the subject |
| Arm 3 - Iopamidol 300mgI/mL | ACTIVE_COMPARATOR | Given as a single administration to the subject |
| Name | Type | Description |
|---|---|---|
| Ioforminol 160 mgI/mL | DRUG | Given as s single administration to the subject |
| Ioforminol 200 mgI/mL | DRUG | Given as a single administration to the subject |
| Iopamidol 300 mgI/mL | DRUG | Given as a single administration to the subject |
Inclusion Criteria: * Healthy males or females between 18 and 50 years of age. * The subject has a maximum abdominal circumference of 120 cm or less. Exclusion Criteria: * The subject has known Grade 3 or 4 allergic reaction/hypersensitivity to either iodine or any iodinated-based contrast agent ...