Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied for bioequivalence, meaning it is being compared to an existing reference product to determine if it produces the same effect in the body. It is intended for use in healthy adult subjects to assess how the body absorbs and processes the drug.
Iron Sucrose is being developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker symbol BAX. The company is conducting clinical trials to evaluate the drug's bioequivalence.
Iron Sucrose is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.
Iron Sucrose has one completed Phase 1 clinical trial registered under NCT04155814, titled 'Bioequivalence Study Assessing Iron Sucrose or Venofer® in Healthy Adult Subjects.' The trial was conducted in the United States with 196 healthy adult participants.
Iron Sucrose is being studied as a potential generic or biosimilar version of Venofer, which is a brand-name iron sucrose product. The clinical trial compares Iron Sucrose to Venofer to assess whether the two are bioequivalent in healthy adults.