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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-29

Study Completion Date

2019-01-15

Brief Summary

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

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Detailed Description

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Conditions

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Iron Deficiency Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Ferric carboxymaltose (test)

Patients will receive a single dose of Ferric carboxymaltose

Group Type EXPERIMENTAL

Ferric carboxymaltose

Intervention Type DRUG

750 mg/15 mL

Ferric carboxymaltose (reference)

Patients will receive a single dose of Ferric carboxymaltose

Group Type ACTIVE_COMPARATOR

Ferric carboxymaltose

Intervention Type DRUG

750 mg/15 mL

Interventions

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Ferric carboxymaltose

750 mg/15 mL

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No