Status:
COMPLETED
A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia
Lead Sponsor:
Sandoz
Conditions:
Iron Deficiency Anemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2019
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT03399084
Start Date
November 29 2017
End Date
January 15 2019
Last Update
May 30 2019
Active Locations (1)
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1
Sandoz Investigative Site
Miami, Florida, United States, 33143