McKesson Corporation, Salem, MA, USA.
Curr Med Res Opin. 2011 Aug;27(8):1653-7. doi: 10.1185/03007995.2011.597738. Epub 2011 Jun 30.
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.
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.
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%.
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.
复方注射用蔗糖铁（Ferrlecit [商品名 SFG]）用于治疗接受慢性血液透析和补充促红细胞生成素的缺铁性贫血患者。这项比较药代动力学研究（GeneraMedix，Inc.，研究 17909）评估了最近批准的仿制药 Nulecit（仿制药 SFG）和品牌药 Ferrlecit（品牌药 SFG）是否生物等效。
在这项开放标签研究中，240 名处于禁食状态的健康志愿者被随机分配至单次 10 分钟静脉内（IV）输注 125mg 仿制药或品牌药 SFG。在输注后 36 小时内测定总铁和转铁蛋白结合铁浓度，并校正预处理水平。比较两种产品的最大浓度（Cmax）和 0 至 36 小时的浓度-时间曲线下面积（AUC[0-36]）。仿制药 SFG 的每个参数的 90%置信区间均在品牌药 SFG 相应值的 80%至 125%范围内，即可证明生物等效性。
在 36 小时评估期间，未校正和基线校正的总血清铁血清浓度在仿制药和品牌药 SFG 之间相似。对于总血清铁，校正的 Cmax 和 AUC[0-36]的几何均数比值为 100%。对于转铁蛋白结合铁，校正的 Cmax 和校正的 AUC[0-36]的几何均数比值分别为 87%和 92%。所有相关的 90%置信区间均在 80%至 125%范围内。
新的复方静脉注射用蔗糖铁（SFG）仿制药与静脉注射用 SFG 品牌药生物等效。仿制药 SFG 被 FDA 评为 AB 级，被认为与品牌产品具有治疗等效性。
