Sodium ferric gluconate (SFG) in complex with sucrose for IV infusion: bioequivalence of a new generic product with the branded product in healthy volunteers

Abstract

Objective:

Parenteral sodium ferric gluconate in complex (Ferrlecit [branded SFG]) is used to treat patients with iron deficiency anemia undergoing chronic hemodialysis and receiving supplemental epoetin. This comparative pharmacokinetic study (GeneraMedix, Inc., Study 17909) evaluates whether the recently approved generic product Nulecit (generic SFG) and the branded product Ferrlecit (branded SFG) are bioequivalent.

Methods:

In this open-label study, 240 healthy volunteers in a fasting state were assigned randomly to a single 10-min intravenous (IV) infusion of 125 mg of generic or branded SFG. Total and transferrin-bound iron concentrations were determined for the 36-h period after infusion and corrected for pretreatment levels. Maximum concentration (Cmax) and area under the concentration–time curve of 0 to 36 h (AUC[0–36]) were compared between the two products. Demonstration of bioequivalence required that the 90% confidence intervals of each parameter evaluated for generic SFG were within 80% to 125% of the corresponding values for branded SFG.

Results:

Uncorrected and baseline-corrected mean serum concentrations of total serum iron during the 36-h assessment period were similar for generic and branded SFG. For total serum iron, the geometric mean ratios of corrected Cmax and AUC[0–36] were 100%. For transferrin-bound iron, the geometric mean ratios were 87% for corrected Cmax and 92% for corrected AUC[0–36]. All associated 90% confidence intervals were within the range of 80% to 125%.

Conclusions:

A new generic SFG in complex for IV infusion is bioequivalent to the branded SFG in complex for IV infusion. The generic SFG is AB rated by the FDA and considered therapeutically equivalent to the branded product.

Key words::

• Equivalency, therapeutic
• Ferric gluconate
• Ferrlecit
• Nulecit
• Pharmacokinetics

Transparency

Declaration of funding

This study was sponsored by GeneraMedix, Inc.

Declaration of financial/other relationships

David Baribeault has disclosed that he is a consultant for, on the speakers bureau of and has received research funding from Watson Pharma, Inc. He has also disclosed the following: Amgen, Inc. – consultant, speakers bureau; Genentech – consultant; Eisai – consultant, speakers bureau; Hospira – consultant.

Acknowledgments

David Baribeault contributed to the analysis and interpretation of the study results, wrote the manuscript, and reviewed and approved the final draft.

GeneraMedix, Inc. contributed to the study design and data collection and reviewed the manuscript for scientific accuracy.

Watson Laboratories, Inc. reviewed the manuscript for scientific accuracy and completeness.

Scientific Connexions (Newtown, Pennsylvania) provided editorial assistance with funding from Watson Pharma, Inc.

Notes

* Ferrlecit is a registered trademark of A. Nattermann & Cie. GmbH.

† Nulecit is a registered trademark of Watson Pharmaceuticals, Inc.