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.