A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia

An Open-label, Randomized, Parallel, Bioequivalence Study of 750 mg Intravenous Single Dose Ferric Carboxymaltose Versus Injectafer® (750 mg Iron/15 mL Colloidal Solution) in Adult Patients With Iron Deficiency Anemia

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03399084

Enrollment

Registered

2018-01-16

Start date

2017-11-29

Completion date

2019-01-15

Last updated

2019-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency Anemia

Keywords

Ferric carboxymaltose, Anemia

Brief summary

This study will evaluate bioequivalence of two formulations of Ferric Carboxymaltose as measured by serum total iron, in adult patients with iron deficiency anemia.

Interventions

DRUGFerric carboxymaltose

750 mg/15 mL

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Male and female patients at least 18 - 65 years of age; * Patients with a body mass index (BMI) between 18.5 - 35 and with a body weight of ≥50 kg - ≤130 kg;

Exclusion criteria

* Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product * Patients with chronic kidney disease who are on dialysis of any kind. * If female, is pregnant or nursing. * Patients with blood loss leading to hemodynamic instability * Patients with recent parenteral iron within 3 months prior to screening. Other inclusion/

Design outcomes

Primary

Measure	Time frame	Description
Bioequivalence assessed by maximum serum concentration (Cmax)of serum total iron.	Up to 7 days	Measured by Cmax - The maximum plasma concentration of iron
Bioequivalence assessed by area under the serum concentration-time curve (AUC) of serum total iron.	Up to 7 Days	Plasma Pharmacokinetics (PK) of study medication: Area Under the Plasma Concentration-time Curve (AUC)

Secondary

Measure	Time frame	Description
Area under the serum concentration-time curve (AUC) of serum transferrin-bound iron	Up to 7 Days	Plasma Pharmacokinetics (PK): area under the serum concentration-time curve (AUC)
Apparent terminal rate constant of serum total iron and transferrin-bound iron	Up to 7 Days	Plasma Pharmacokinetics (PK): Apparent terminal rate constant
Apparent terminal half-life of serum total iron and transferrin-bound iron	Up to 7 Days	Plasma Pharmacokinetics (PK): Apparent terminal half-life
Maximum serum concentration (Cmax) of serum transferrin-bound iron.	Up to 7 days	Plasma Pharmacokinetics (PK): The maximum plasma concentration
Volume of distribution at steady state of serum total iron and transferrin-bound iron following intravenous dosing	Up to 7 Days	Plasma Pharmacokinetics (PK): Volume of distribution at steady state Plasma Pharmacokinetics (PK): Volume of distribution at steady state (Vss)
Number of patients with adverse events as a measure of safety and tolerability	Up to 7 days	—
Systemic clearance (CL) of serum total iron and transferrin-bound iron after intravenous dosing	Up to 7 Days	Plasma Pharmacokinetics (PK): Systemic clearance (CL)
Time of Cmax (Tmax) of serum total iron and transferrin-bound iron	Up to 7 Days	Plasma Pharmacokinetics (PK): Time of Cmax (Tmax)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026