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

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

Sponsors

Lead sponsor: Sandoz

Source 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.

Overall Status Completed
Start Date November 29, 2017
Completion Date January 15, 2019
Primary Completion Date January 15, 2019
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Bioequivalence assessed by maximum serum concentration (Cmax)of serum total iron. Up to 7 days
Bioequivalence assessed by maximum serum concentration (Cmax)of serum total iron. Up to 7 days
Bioequivalence assessed by maximum serum concentration (Cmax)of serum total iron. Up to 7 days
Bioequivalence assessed by area under the serum concentration-time curve (AUC) of serum total iron. Up to 7 Days
Bioequivalence assessed by area under the serum concentration-time curve (AUC) of serum total iron. Up to 7 Days
Bioequivalence assessed by area under the serum concentration-time curve (AUC) of serum total iron. Up to 7 Days
Secondary Outcome
Measure Time Frame
Maximum serum concentration (Cmax) of serum transferrin-bound iron. Up to 7 days
Time of Cmax (Tmax) of serum total iron and transferrin-bound iron Up to 7 Days
Area under the serum concentration-time curve (AUC) of serum transferrin-bound iron Up to 7 Days
Apparent terminal rate constant of serum total iron and transferrin-bound iron Up to 7 Days
Apparent terminal half-life of serum total iron and transferrin-bound iron Up to 7 Days
Systemic clearance (CL) of serum total iron and transferrin-bound iron after intravenous dosing Up to 7 Days
Volume of distribution at steady state of serum total iron and transferrin-bound iron following intravenous dosing Up to 7 Days
Number of patients with adverse events as a measure of safety and tolerability Up to 7 days
Enrollment 71
Condition
Intervention

Intervention type: Drug

Intervention name: Ferric carboxymaltose

Description: 750 mg/15 mL

Eligibility

Criteria:

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.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Sandoz Sandoz Study Director Novartis Pharmaceuticals
Location
facility
Sandoz Investigative Site
Location Countries

United States

Verification Date

May 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Ferric carboxymaltose (test)

Arm group type: Experimental

Description: Patients will receive a single dose of Ferric carboxymaltose

Arm group label: Ferric carboxymaltose (reference)

Arm group type: Active Comparator

Description: Patients will receive a single dose of Ferric carboxymaltose

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov