Healthy
Conditions
Keywords
Use in Abdominal, Contrast Enhanced, Computed Tomography, Optimize concentration, dosage of Ioforminol Injection
Brief summary
To optimize both the Ioforminol concentration and dosage(s) for CECT of the abdomen. To evaluate the safety and tolerability of low concentration Ioforminol Injections. Study recruits healthy volunteers.
Interventions
DRUGIoforminol 160 mgI/mL
Given as s single administration to the subject
DRUGIoforminol 200 mgI/mL
Given as a single administration to the subject
DRUGIopamidol 300 mgI/mL
Given as a single administration to the subject
Sponsors
Physician Reference Laboratory
Quintiles, Inc.
GE Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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 or with history of multiple allergies (i.e., foods, pets, medications, etc). * The subject has chronic renal insufficiency (estimated glomerular filtration rate \[eGFR\] \<60 mg/dL) as measured at the screening visit. * The subject is pregnant or breast-feeding. * The subject has suspicion or diagnosis of hyperthyroidism or autonomously functioning thyroid nodule confirmed by T3, T4, and/or thyroid-stimulating hormone. * The subject has severe liver or hematologic diseases (sickle cell disease or multiple myeloma), or immunodeficiency. * The subject is taking metformin (e.g., Glucophage®) therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). | Within 5 minutes after administration for either Ioforminol or Iopamidol. | 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. |
| Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). | Within 5 minutes after administration for either Ioforminol or Iopamidol. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Up to 72 hours for safety monitoring post Ioforminol and Iopamidol administration. | Recording the occurrence of treatment emergent adverse events (TEAE). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.0mL/kg. | 10 |
| Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.5mL/kg. | 10 |
| Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 2.0mL/kg. | 10 |
| Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.0mL/Kg | 10 |
| Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.5mL/Kg | 10 |
| Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 2.0mL/Kg | 10 |
| Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg Iopamidol 300 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.0mL/Kg | 6 |
| Total | 66 |
Baseline characteristics
| Characteristic | Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg | Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg | Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg | Total | Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg | Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg | Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg | Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg |
|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 6 Participants | 66 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants |
| Region of Enrollment United States | 10 Participants | 10 Participants | 6 Participants | 66 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 2 Participants | 35 Participants | 5 Participants | 4 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 4 Participants | 31 Participants | 5 Participants | 6 Participants | 6 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 10 | 5 / 10 | 10 / 10 | 8 / 10 | 5 / 10 | 7 / 10 | 5 / 6 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 6 |
Outcome results
Primary
Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).
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.
Time frame: Within 5 minutes after administration for either Ioforminol or Iopamidol.
Population: Evaluted 33 subjects using 100 kilovolt peak (kVp), a measure of the maximum electrical potential in kilovolts across an x-ray. tube.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg | Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). | 191 Hounsfield Units | Standard Deviation 34.6 |
| Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg | Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). | 230 Hounsfield Units | Standard Deviation 40.2 |
| Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg | Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). | 212 Hounsfield Units | Standard Deviation 22.2 |
| Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg | Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). | 261 Hounsfield Units | Standard Deviation 37.7 |
| Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg | Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). | 246 Hounsfield Units | Standard Deviation 36.6 |
| Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg | Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). | 240 Hounsfield Units | Standard Deviation 49.4 |
| Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg | Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). | 257 Hounsfield Units | Standard Deviation 9.5 |
Primary
Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).
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.
Time frame: Within 5 minutes after administration for either Ioforminol or Iopamidol.
Population: Evaluted 33 subjects using 80 kilovolt peak (kVp), a measure of the maximum electrical potential in kilovolts across an x-ray.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg | Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). | 168 Hounsfield Units | Standard Deviation 41 |
| Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg | Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). | 261 Hounsfield Units | Standard Deviation 56.5 |
| Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg | Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). | 345 Hounsfield Units | Standard Deviation 30.7 |
| Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg | Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). | 341 Hounsfield Units | Standard Deviation 33.6 |
| Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg | Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). | 357 Hounsfield Units | Standard Deviation 30.1 |
| Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg | Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). | 365 Hounsfield Units | Standard Deviation 67.7 |
| Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg | Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). | 331 Hounsfield Units | Standard Deviation 53.7 |
Secondary
Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE).
Recording the occurrence of treatment emergent adverse events (TEAE).
Time frame: Up to 72 hours for safety monitoring post Ioforminol and Iopamidol administration.
Population: These are the numbers of Treatment Emergent Adverse Events (TEAE) and TEAEs related to Investigational Medicinal Product (IMP).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Deaths | 0 Adverse Events |
| Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Any Treatment Emergent Adverse Events-IMP | 2 Adverse Events |
| Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Serious TEAEs | 0 Adverse Events |
| Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Any Treatment Emergent Adverse Events (TEAE) | 3 Adverse Events |
| Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Intensity-Mild | 3 Adverse Events |
| Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Withdrawals due to Adverse Events | 0 Adverse Events |
| Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Any Treatment Emergent Adverse Events (TEAE) | 5 Adverse Events |
| Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Serious TEAEs | 0 Adverse Events |
| Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Deaths | 0 Adverse Events |
| Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Any Treatment Emergent Adverse Events-IMP | 5 Adverse Events |
| Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Withdrawals due to Adverse Events | 0 Adverse Events |
| Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Intensity-Mild | 5 Adverse Events |
| Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Withdrawals due to Adverse Events | 0 Adverse Events |
| Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Intensity-Mild | 13 Adverse Events |
| Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Deaths | 0 Adverse Events |
| Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Serious TEAEs | 0 Adverse Events |
| Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Any Treatment Emergent Adverse Events (TEAE) | 13 Adverse Events |
| Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Any Treatment Emergent Adverse Events-IMP | 13 Adverse Events |
| Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Withdrawals due to Adverse Events | 0 Adverse Events |
| Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Any Treatment Emergent Adverse Events (TEAE) | 8 Adverse Events |
| Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Any Treatment Emergent Adverse Events-IMP | 8 Adverse Events |
| Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Intensity-Mild | 8 Adverse Events |
| Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Serious TEAEs | 0 Adverse Events |
| Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Deaths | 0 Adverse Events |
| Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Serious TEAEs | 0 Adverse Events |
| Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Any Treatment Emergent Adverse Events-IMP | 5 Adverse Events |
| Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Withdrawals due to Adverse Events | 0 Adverse Events |
| Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Deaths | 0 Adverse Events |
| Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Intensity-Mild | 5 Adverse Events |
| Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Any Treatment Emergent Adverse Events (TEAE) | 5 Adverse Events |
| Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Intensity-Mild | 7 Adverse Events |
| Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Serious TEAEs | 0 Adverse Events |
| Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Any Treatment Emergent Adverse Events-IMP | 7 Adverse Events |
| Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Withdrawals due to Adverse Events | 0 Adverse Events |
| Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Any Treatment Emergent Adverse Events (TEAE) | 7 Adverse Events |
| Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Deaths | 0 Adverse Events |
| Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Intensity-Mild | 5 Adverse Events |
| Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Any Treatment Emergent Adverse Events-IMP | 5 Adverse Events |
| Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Deaths | 0 Adverse Events |
| Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Serious TEAEs | 0 Adverse Events |
| Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Withdrawals due to Adverse Events | 0 Adverse Events |
| Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Any Treatment Emergent Adverse Events (TEAE) | 5 Adverse Events |