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

Iron Deficiency Anemia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03399084
• Other study ID #: 1637 FCM_1
• Status: Completed
• Phase: Phase 1
• Start date: November 29, 2017
• Est. completion date: January 15, 2019

Study information

• Verified date: May 2019
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 15, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

Drug:
• Ferric carboxymaltose
750 mg/15 mL

Locations

Country	Name	City	State
United States	Sandoz Investigative Site	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence assessed by maximum serum concentration (Cmax)of serum total iron.	Measured by Cmax - The maximum plasma concentration of iron	Up to 7 days
Primary	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	Maximum serum concentration (Cmax) of serum transferrin-bound iron.	Plasma Pharmacokinetics (PK): The maximum plasma concentration	Up to 7 days
Secondary	Time of Cmax (Tmax) of serum total iron and transferrin-bound iron	Plasma Pharmacokinetics (PK): Time of Cmax (Tmax)	Up to 7 Days
Secondary	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
Secondary	Apparent terminal rate constant of serum total iron and transferrin-bound iron	Plasma Pharmacokinetics (PK): Apparent terminal rate constant	Up to 7 Days
Secondary	Apparent terminal half-life of serum total iron and transferrin-bound iron	Plasma Pharmacokinetics (PK): Apparent terminal half-life	Up to 7 Days
Secondary	Systemic clearance (CL) of serum total iron and transferrin-bound iron after intravenous dosing	Plasma Pharmacokinetics (PK): Systemic clearance (CL)	Up to 7 Days
Secondary	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
Secondary	Number of patients with adverse events as a measure of safety and tolerability		Up to 7 days