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COMPLETEDPhase 1NCT03399084

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

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

Lead sponsor: Sandoz•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Sandoz

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 30, 2019Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment71

Start dateNov 2017

Last updatedMay 30, 2019

Condition

Iron Deficiency Anemia

Locations shown

Sandoz Investigative Site

Miami, Florida

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 30, 2019Data synced to Clareo: April 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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