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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03399084 | A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia | PHASE1 | COMPLETED | 71 | — | — | Nov 29, 2017 | Jan 15, 2019 | May 30, 2019 | 1 | United States |
Measured by Cmax - The maximum plasma concentration of iron
Plasma Pharmacokinetics (PK) of study medication: Area Under the Plasma Concentration-time Curve (AUC)
| Arm | Type | Description |
|---|---|---|
| Ferric carboxymaltose (test) | EXPERIMENTAL | Patients will receive a single dose of Ferric carboxymaltose |
| Ferric carboxymaltose (reference) | ACTIVE_COMPARATOR | Patients will receive a single dose of Ferric carboxymaltose |
| Name | Type | Description |
|---|---|---|
| Ferric carboxymaltose | DRUG | 750 mg/15 mL |
Inclusion Criteria: * Male and female patients at least 18 - 65 years of age; * Patients with a body mass index (BMI) between 18.5 - 35 and with a body weight of ≥50 kg - ≤130 kg; Exclusion Criteria: * Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product *...