The objective of this study is to evaluate the therapeutic equivalence of generic sodium ferric gluconate iron complex NulecitTM and its RLD Ferrlecit®. Specific aims are: 1) compare reticuloendothelial system (RES) uptake of RLD and generic; 2) compare biodistribution of the RLD and generic in animal models; 3) conduct in-vivo study to compare plasma NTBI levels and oxidative stress after i.v. administration of RLD and generic in healthy subjects or patients. This study is part of post-market surveillance that can help address potential concerns regarding the quality of generic iron complex products and support the Agency's review standards
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