A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia
| Status: | Recruiting |
|---|---|
| Conditions: | Iron Deficiency Anemia, Anemia, Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/17/2018 |
| Start Date: | November 29, 2017 |
| End Date: | December 31, 2018 |
| Contact: | Sandoz |
| Email: | novartis.email@novartis.com |
| Phone: | 862-778-8300 |
An Open-label, Randomized, Parallel, Bioequivalence Study of 750 mg Intravenous Single Dose Ferric Carboxymaltose Versus Injectafer® (750 mg Iron/15 mL Colloidal Solution) in Adult 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.
measured by serum total iron, in adult patients with iron deficiency anemia.
Inclusion Criteria:
- Male and female patients at least 18 - 65 years of age;
- Patients with a body mass index (BMI) between 18.5 - 30 and with a body weight of 50
kg or above;
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.
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