Completed
A Phase 1/2, Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Contrast-Enhanced Abdominal Computed Tomography in Healthy Volunteers
What is being tested
Ioforminol 160 mgI/mL
+ Ioforminol 200 mgI/mL
+ Iopamidol 300 mgI/mL
Drug
Who is being recruted
From 18 to 50 Years
+8 Eligibility Criteria
How is the trial designed
Diagnostic Study
Phase 1 & 2
Interventional
Study Start: July 2012
Summary
Principal SponsorGE Healthcare
Last updated: May 29, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorGE Healthcare
Last updated: May 29, 2014
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
66 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
2 inclusion criteria required to participate
Healthy males or females between 18 and 50 years of age
The subject has a maximum abdominal circumference of 120 cm or less
6 exclusion criteria prevent from participating
The subject has chronic renal insufficiency (estimated glomerular filtration rate [eGFR] < 60 mg/dL) as measured at the screening visit
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 severe liver or hematologic diseases (sickle cell disease or multiple myeloma), or immunodeficiency
The subject has suspicion or diagnosis of hyperthyroidism or autonomously functioning thyroid nodule confirmed by T3, T4, and/or thyroid-stimulating hormone
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalSingle administration of Ioforminol 160mgI/mL given to the subject.
Group II
ExperimentalGiven as a single administration to the subject
Group III
Active ComparatorGiven as a single administration to the subject
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center