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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric carboxymaltose (test) | Experimental | Patients will receive a single dose of Ferric carboxymaltose |
|
| Ferric carboxymaltose (reference) | Active Comparator | Patients will receive a single dose of Ferric carboxymaltose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric carboxymaltose | Drug | 750 mg/15 mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence assessed by maximum serum concentration (Cmax)of serum total iron. | Measured by Cmax - The maximum plasma concentration of iron | Up to 7 days |
| Bioequivalence assessed by area under the serum concentration-time curve (AUC) of serum total iron. | Plasma Pharmacokinetics (PK) of study medication: Area Under the Plasma Concentration-time Curve (AUC) | Up to 7 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum serum concentration (Cmax) of serum transferrin-bound iron. | Plasma Pharmacokinetics (PK): The maximum plasma concentration | Up to 7 days |
| Time of Cmax (Tmax) of serum total iron and transferrin-bound iron |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Sandoz Sandoz | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandoz Investigative Site | Miami | Florida | 33143 | United States |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
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Plasma Pharmacokinetics (PK): Time of Cmax (Tmax)
| Up to 7 Days |
| Area under the serum concentration-time curve (AUC) of serum transferrin-bound iron | Plasma Pharmacokinetics (PK): area under the serum concentration-time curve (AUC) | Up to 7 Days |
| Apparent terminal rate constant of serum total iron and transferrin-bound iron | Plasma Pharmacokinetics (PK): Apparent terminal rate constant | Up to 7 Days |
| Apparent terminal half-life of serum total iron and transferrin-bound iron | Plasma Pharmacokinetics (PK): Apparent terminal half-life | Up to 7 Days |
| Systemic clearance (CL) of serum total iron and transferrin-bound iron after intravenous dosing | Plasma Pharmacokinetics (PK): Systemic clearance (CL) | Up to 7 Days |
| Volume of distribution at steady state of serum total iron and transferrin-bound iron following intravenous dosing | Plasma Pharmacokinetics (PK): Volume of distribution at steady state Plasma Pharmacokinetics (PK): Volume of distribution at steady state (Vss) | Up to 7 Days |
| Number of patients with adverse events as a measure of safety and tolerability | Up to 7 days |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |