Trials / Completed
CompletedNCT03399084
A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 71 (actual)
- Sponsor
- Sandoz · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ferric carboxymaltose | 750 mg/15 mL |
Timeline
- Start date
- 2017-11-29
- Primary completion
- 2019-01-15
- Completion
- 2019-01-15
- First posted
- 2018-01-16
- Last updated
- 2019-05-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03399084. Inclusion in this directory is not an endorsement.