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Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Abdominal CECT in Healthy Volunteers

NCT01672996 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2014-05-29

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

Ioforminol 160 mgI/mL

Given as s single administration to the subject

DRUG

Ioforminol 200 mgI/mL

Given as a single administration to the subject

DRUG

Iopamidol 300 mgI/mL

Given as a single administration to the subject

Sponsors & Collaborators

  • Physician Reference Laboratory

    collaborator UNKNOWN

  • Quintiles, Inc.

    collaborator INDUSTRY

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Rubin Sheng, MD · GE Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01672996 on ClinicalTrials.gov