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

Completed · Phase 1

Conditions studied: Iron Deficiency Anemia

In brief

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

Key facts

Study ID

NCT03399084

Run by

Sandoz

People needed

71

Starts

2017-11-29

Expected to finish

2019-01-15

Last updated by the study team

2019-05-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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.

Where it is running

• Sandoz Investigative Site — Miami, Florida, United States

Full record on ClinicalTrials.gov

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