Evalution of Iron Species in Healthy Subjects treated with Generic and Reference Sodium Ferric Gluconate

This study is part of post-market surveillance on approved generic products, which can help address potential concerns regarding the quality of generic iron complex products and support the Agency’s review standards. Detailed Descriptions: A prospective, randomized, 2-way crossover study to compare plasma TI, TBI, NTBI levels in healthy subjects treated with generic and reference sodium ferric gluconate injections is preferred. Utilize in vitro and in vivo biomarkers such as malondialdehyde, heme-oxygenase-1 (HO-1) RNA or others to evaluate the oxidative stress and toxicity caused by generic and RLD products. 1. Collect marketed brand and generic sodium ferric gluconate products and compare them in terms of potency, impurity, and other drug product quality attributes. 2. Develop bio-analytical methods to determine plasma TI, TBI, and NTBI concentrations. 3. Conduct a prospective, randomized, 2-way crossover study to compare plasma TI, TBI, NTBI levels in healthy subjects treated with generic and RLD. Monitor TBI, total iron binding capacity and serum ferritin level during washout period to ensure iron storage and transport has returned to baseline. 4. Evaluate the oxidative stress and toxicity caused by generic and RLD using in vitro and in vivo biomarkers. 5. Monitor any side effects or adverse reactions during the study period. 6. Conduct statistical analysis to determine whether there are any significant differences between generic and RLD in NTBI level and o...
Source: Grants.gov - Category: Research Tags: Health Science and Technology and other Research and Development Source Type: funding