Overview

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

Status:
Completed
Trial end date:
2019-01-15
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sandoz
Treatments:
Ferric Compounds
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.