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Relative Bioavailability of CE-Iohexol (Captisol-enabled™ Iohexol) Injection and Omnipaque™ Injection

NCT03869983 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-08-16

No results posted yet for this study

Summary

This study is designed to compare the bioavailability of the test Product(CE-Iohexol Injection) and the reference product Iohexol Injection (Omnipaque™) following intravenous injection in normal healthy volunteers. The secondary objective is to assess the safety and tolerability of the treatments administered. Captisol® is present to improve stability and to potentially reduce the risk of contrast-induced acute kidney injury(CI-AKI) associated with iohexol administration.

Conditions

  • Contrast-induced Nephropathy
  • Coronary Angiography

Interventions

OTHER

Omnipaque™ (iohexol) Injection

755 mg/mL iohexol (350 mgI/mL), 80 mL infused intravenously over approximately 20 seconds

OTHER

CE-Iohexol

755 mg/mL iohexol (350 mgI/mL)/50 mg CAPTISOL®/mL, 80 mL infused intravenously over approximately 20 seconds

Sponsors & Collaborators

  • Ligand Pharmaceuticals

    collaborator INDUSTRY

  • Syneos Health

    collaborator OTHER

  • CyDex Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Keith Marschke, PhD · Ligand Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-12
Primary Completion
2019-05-15
Completion
2019-06-15

Countries

  • Canada

Study Locations

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Entities

Companies

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 NCT03869983 on ClinicalTrials.gov