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Completed

NCT Number: NCT03399084

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

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

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sandoz Investigative Site

Miami, Florida, 33143, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ferric carboxymaltose

Drug

750 mg/15 mL

Primary outcomes

  1. Bioequivalence assessed by maximum serum concentration (Cmax)of serum total iron.

    Time frame: Up to 7 days

    Measured by Cmax - The maximum plasma concentration of iron

  2. Bioequivalence assessed by area under the serum concentration-time curve (AUC) of serum total iron.

    Time frame: Up to 7 Days

    Plasma Pharmacokinetics (PK) of study medication: Area Under the Plasma Concentration-time Curve (AUC)

Secondary outcomes

  1. Maximum serum concentration (Cmax) of serum transferrin-bound iron.

    Time frame: Up to 7 days

    Plasma Pharmacokinetics (PK): The maximum plasma concentration

  2. Time of Cmax (Tmax) of serum total iron and transferrin-bound iron

    Time frame: Up to 7 Days

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

  3. Area under the serum concentration-time curve (AUC) of serum transferrin-bound iron

    Time frame: Up to 7 Days

    Plasma Pharmacokinetics (PK): area under the serum concentration-time curve (AUC)

  4. Apparent terminal rate constant of serum total iron and transferrin-bound iron

    Time frame: Up to 7 Days

    Plasma Pharmacokinetics (PK): Apparent terminal rate constant

  5. Apparent terminal half-life of serum total iron and transferrin-bound iron

    Time frame: Up to 7 Days

    Plasma Pharmacokinetics (PK): Apparent terminal half-life

  6. Systemic clearance (CL) of serum total iron and transferrin-bound iron after intravenous dosing

    Time frame: Up to 7 Days

    Plasma Pharmacokinetics (PK): Systemic clearance (CL)

  7. Volume of distribution at steady state of serum total iron and transferrin-bound iron following intravenous dosing

    Time frame: Up to 7 Days

    Plasma Pharmacokinetics (PK): Volume of distribution at steady state Plasma Pharmacokinetics (PK): Volume of distribution at steady state (Vss)

  8. Number of patients with adverse events as a measure of safety and tolerability

    Time frame: Up to 7 days

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 16, 2018
Registry last updated
May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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