Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04155814 | Bioequivalence Study Assessing Iron Sucrose or Venofer® in Healthy Adult Subjects | PHASE1 | COMPLETED | 196 | — | — | Sep 19, 2019 | Dec 18, 2019 | Jul 31, 2020 | 1 | United States |
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...