A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia
- Registration Number
- NCT03399084
- Lead Sponsor
- Sandoz
- Brief Summary
This study will evaluate bioequivalence of two formulations of Ferric Carboxymaltose as measured by serum total iron, in adult patients with iron deficiency anemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- 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;
- Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product
- Patients with chronic kidney disease who are on dialysis of any kind.
- If female, is pregnant or nursing.
- Patients with blood loss leading to hemodynamic instability
- Patients with recent parenteral iron within 3 months prior to screening.
Other inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ferric carboxymaltose (reference) Ferric carboxymaltose Patients will receive a single dose of Ferric carboxymaltose Ferric carboxymaltose (test) Ferric carboxymaltose Patients will receive a single dose of Ferric carboxymaltose
- Primary Outcome Measures
Name Time Method Bioequivalence assessed by maximum serum concentration (Cmax)of serum total iron. Up to 7 days Measured by Cmax - The maximum plasma concentration of iron
Bioequivalence assessed by area under the serum concentration-time curve (AUC) of serum total iron. Up to 7 Days Plasma Pharmacokinetics (PK) of study medication: Area Under the Plasma Concentration-time Curve (AUC)
- Secondary Outcome Measures
Name Time Method Maximum serum concentration (Cmax) of serum transferrin-bound iron. Up to 7 days Plasma Pharmacokinetics (PK): The maximum plasma concentration
Time of Cmax (Tmax) of serum total iron and transferrin-bound iron Up to 7 Days Plasma Pharmacokinetics (PK): Time of Cmax (Tmax)
Area under the serum concentration-time curve (AUC) of serum transferrin-bound iron Up to 7 Days Plasma Pharmacokinetics (PK): area under the serum concentration-time curve (AUC)
Apparent terminal rate constant of serum total iron and transferrin-bound iron Up to 7 Days Plasma Pharmacokinetics (PK): Apparent terminal rate constant
Apparent terminal half-life of serum total iron and transferrin-bound iron Up to 7 Days Plasma Pharmacokinetics (PK): Apparent terminal half-life
Systemic clearance (CL) of serum total iron and transferrin-bound iron after intravenous dosing Up to 7 Days Plasma Pharmacokinetics (PK): Systemic clearance (CL)
Volume of distribution at steady state of serum total iron and transferrin-bound iron following intravenous dosing Up to 7 Days Plasma Pharmacokinetics (PK): Volume of distribution at steady state Plasma Pharmacokinetics (PK): Volume of distribution at steady state (Vss)
Number of patients with adverse events as a measure of safety and tolerability Up to 7 days
Trial Locations
- Locations (1)
Sandoz Investigative Site
🇺🇸Miami, Florida, United States
Sandoz Investigative Site🇺🇸Miami, Florida, United States