This study will evaluate bioequivalence of two formulations of Ferric Carboxymaltose as measured by serum total iron, in adult patients with iron deficiency anemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
71
750 mg/15 mL
Sandoz Investigative Site
Miami, Florida, United States
Bioequivalence assessed by maximum serum concentration (Cmax)of serum total iron.
Measured by Cmax - The maximum plasma concentration of iron
Time frame: Up to 7 days
Bioequivalence assessed by area under the serum concentration-time curve (AUC) of serum total iron.
Plasma Pharmacokinetics (PK) of study medication: Area Under the Plasma Concentration-time Curve (AUC)
Time frame: Up to 7 Days
Maximum serum concentration (Cmax) of serum transferrin-bound iron.
Plasma Pharmacokinetics (PK): The maximum plasma concentration
Time frame: Up to 7 days
Time of Cmax (Tmax) of serum total iron and transferrin-bound iron
Plasma Pharmacokinetics (PK): Time of Cmax (Tmax)
Time frame: Up to 7 Days
Area under the serum concentration-time curve (AUC) of serum transferrin-bound iron
Plasma Pharmacokinetics (PK): area under the serum concentration-time curve (AUC)
Time frame: Up to 7 Days
Apparent terminal rate constant of serum total iron and transferrin-bound iron
Plasma Pharmacokinetics (PK): Apparent terminal rate constant
Time frame: Up to 7 Days
Apparent terminal half-life of serum total iron and transferrin-bound iron
Plasma Pharmacokinetics (PK): Apparent terminal half-life
Time frame: Up to 7 Days
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Systemic clearance (CL) of serum total iron and transferrin-bound iron after intravenous dosing
Plasma Pharmacokinetics (PK): Systemic clearance (CL)
Time frame: Up to 7 Days
Volume of distribution at steady state of serum total iron and transferrin-bound iron following intravenous dosing
Plasma Pharmacokinetics (PK): Volume of distribution at steady state Plasma Pharmacokinetics (PK): Volume of distribution at steady state (Vss)
Time frame: Up to 7 Days
Number of patients with adverse events as a measure of safety and tolerability
Time frame: Up to 7 days