NCT04155814

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

Bioequivalence Study Assessing a Single Dose of Iron Sucrose Injection (Baxter) or a Single Dose of Venofer® Injection in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-09-19
• Primary completion: 2019-12-18
• Completion: 2019-12-18
• First posted: 2019-11-07
• Last updated: 2020-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study