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

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

Official Title
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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

Conditions
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Iron Deficiency Anemia

Intervention / Treatment
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* Drug: Ferric carboxymaltose


Participation Criteria
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Eligibility Criteria
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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/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferric carboxymaltose (test)<br>Patients will receive a single dose of Ferric carboxymaltose | Drug: Ferric carboxymaltose<br>* 750 mg/15 mL<br>|
| Active Comparator: Ferric carboxymaltose (reference)<br>Patients will receive a single dose of Ferric carboxymaltose | Drug: Ferric carboxymaltose<br>* 750 mg/15 mL<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ferric carboxymaltose, Anemia