Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Iron Sucrose Injection
Iron Sucrose · 1 trial · 1 indication
Maximum concentration (Cmax) across all time points for the delta difference between Total Iron (TI) and Transferrin Bound Iron (TBI). This is a PK test parameter to compare bioequivalence of two drug products.
Area under the concentration curve (AUC) from time zero to last time of quantifiable concentration (Tlast) for the delta difference in AUC0-t between TI and TBI. This is a PK test parameter to compare bioequivalence of two plasma drug products.
| Arm | Type | Description |
|---|---|---|
| Iron Sucrose Injection | EXPERIMENTAL | IV injection (5 mL), delivered over 5 minutes to subjects that have been fasted for a minimum of 10 hours. |
| Venofer Injection | ACTIVE_COMPARATOR | IV injection (5 mL), delivered over 5 minutes to subjects that have been fasted for a minimum of 10 hours. |
| Name | Type | Description |
|---|---|---|
| Iron Sucrose Injection | DRUG | USP 100 mg/5 mL (20 mg/mL), solution for IV injection, 100 mg unit dose strength |
| Venofer Injection | DRUG | (Iron Sucrose 20 mg/mL), solution for IV injection, 100 mg unit dose strength |
Inclusion Criteria: * Healthy males or non-pregnant, non-lactating healthy females * Age 18 to 55 years of age (both inclusive) * Must, in the opinion of the investigator, be in good health based upon medical history, physical examination (including vital signs and ECGs) and clinical laboratory tes...
Iron Sucrose is an injectable small molecule developed by Baxter International Inc. (ticker BAX). It is also known as Iron Sucrose Injection. The program is in Phase 1 clinical development, and the specific therapeutic indication has not been disclosed.
Iron Sucrose is developed by Baxter International Inc., which trades under the ticker BAX. The company sponsored the clinical trial evaluating the product.
Iron Sucrose is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active.
Iron Sucrose has been studied in one completed Phase 1 trial, NCT04155814, titled a bioequivalence study assessing Iron Sucrose or Venofer in healthy adult subjects. It enrolled 196 participants in the United States, was randomized and active controlled, and included healthy volunteers aged 18 years and older.
Yes, Iron Sucrose Injection is another name for Iron Sucrose. Both names refer to the same Baxter International Inc. product, which is in Phase 1 development.