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Adjusted LOA
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Iron Sucrose · 1 trial · 1 indication
Test: Hospira Iron Sucrose Injection; Reference: Venofer Injection
Test: Hospira Iron Sucrose Injection; Reference: Venofer Injection
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Hospira Iron Sucrose |
| 2 | ACTIVE_COMPARATOR | Venofer |
| Name | Type | Description |
|---|---|---|
| Iron Sucrose | DRUG | Venofer 20 mg/mL |
Inclusion Criteria: 1. Healthy male and female volunteers between 18 and 55 years of age (both inclusive). 2. Having a Body Mass Index (BMI) between 18.5 and 32.0 kg/m2 (both inclusive). 3. If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal lig...
Iron Sucrose is an injectable iron replacement therapy developed by Pfizer, Inc. under the ticker PFE. It is a small molecule product studied in a Phase 1 bioequivalency trial comparing Hospira's generic iron sucrose injection to Venofer. The specific therapeutic indication for this asset is undisclosed.
Pfizer, Inc., which trades under the ticker PFE, is the developer of this Iron Sucrose asset. The company sponsored a Phase 1 bioequivalency study of Hospira's generic iron sucrose injection against the reference product Venofer.
Iron Sucrose is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are ongoing. The completed study was a bioequivalency comparison of Hospira's generic iron sucrose injection to Venofer.
Iron Sucrose has been studied in one completed Phase 1 trial, NCT00719459, titled Bioequivalency Study Comparing Hospira's Generic Iron Sucrose Injection to Venofer. The trial enrolled 60 healthy adult volunteers in the United States, used an active-controlled design, and was randomized but not double-blind.
Iron Sucrose is an investigational asset in Phase 1 development. The only listed trial, NCT00719459, was a completed Phase 1 bioequivalency study in healthy volunteers, so the asset has not advanced beyond early clinical development for the undisclosed indication.