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

Phase 1
Completed
Conditions
Iron Deficiency Anemia
Interventions
Registration Number
NCT03399084
Lead Sponsor
Sandoz
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
71
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;
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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.

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Ferric carboxymaltose (reference)Ferric carboxymaltosePatients will receive a single dose of Ferric carboxymaltose
Ferric carboxymaltose (test)Ferric carboxymaltosePatients will receive a single dose of Ferric carboxymaltose
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
Maximum serum concentration (Cmax) of serum transferrin-bound iron.Up to 7 days

Plasma Pharmacokinetics (PK): The maximum plasma concentration

Time of Cmax (Tmax) of serum total iron and transferrin-bound ironUp to 7 Days

Plasma Pharmacokinetics (PK): Time of Cmax (Tmax)

Area under the serum concentration-time curve (AUC) of serum transferrin-bound ironUp 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 ironUp to 7 Days

Plasma Pharmacokinetics (PK): Apparent terminal rate constant

Apparent terminal half-life of serum total iron and transferrin-bound ironUp to 7 Days

Plasma Pharmacokinetics (PK): Apparent terminal half-life

Systemic clearance (CL) of serum total iron and transferrin-bound iron after intravenous dosingUp to 7 Days

Plasma Pharmacokinetics (PK): Systemic clearance (CL)

Volume of distribution at steady state of serum total iron and transferrin-bound iron following intravenous dosingUp 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 tolerabilityUp to 7 days

Trial Locations

Locations (1)

Sandoz Investigative Site

🇺🇸

Miami, Florida, United States

Sandoz Investigative Site
🇺🇸Miami, Florida, United States
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