MedTrace Logo

Bioequivalence Study Assessing Iron Sucrose or Venofer® in Healthy Adult Subjects

NCT04155814 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2020-07-31

No results posted yet for this study

Summary

This study evaluates the bioequivalence, pharmacokinetic (PK) profile, and safety and tolerability of Iron Sucrose (Test Product) relative to that of Venofer® in healthy subjects.

Conditions

  • Bioequivalance

Interventions

DRUG

Iron Sucrose Injection

USP 100 mg/5 mL (20 mg/mL), solution for IV injection, 100 mg unit dose strength

DRUG

Venofer Injection

(Iron Sucrose 20 mg/mL), solution for IV injection, 100 mg unit dose strength

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • Baxter Healthcare Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-09-19
Primary Completion
2019-12-18
Completion
2019-12-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04155814 on ClinicalTrials.gov