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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Iron Deficiency Anemia

Treatments: Drug: Ferric carboxymaltose

Study type: Interventional

Funder types: Industry

Identifiers

NCT03399084

1637 FCM_1

Details and patient eligibility

About

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

Enrollment: 71 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Ferric carboxymaltose (test)

Experimental group

Description:

Patients will receive a single dose of Ferric carboxymaltose

Treatment:

Drug: Ferric carboxymaltose

Ferric carboxymaltose (reference)

Active Comparator group

Description:

Patients will receive a single dose of Ferric carboxymaltose

Treatment:

Drug: Ferric carboxymaltose