Overview
A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia
Status:
Completed
Completed
Trial end date:
2019-01-15
2019-01-15
Target enrollment:
0
0
Participant gender:
All
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 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
SandozTreatments:
Ferric CompoundsCriteria
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.