Comparing Bioequivalence and Safety of Two Ferric Carboxymaltose Injections in Healthy Adults Under Fasting Conditions

What this Trial Is About

Researchers are evaluating the pharmacokinetic profile and safety of two ferric carboxymaltose injections in healthy adult participants under fasting conditions. The study aims to determine if there is a significant difference between the test product provided by Sichuan Huiyu Pharmaceutical Co., Ltd. and the reference product licensed by American Regent, Inc. Injectafer in terms of iron absorption and distribution. The trial is a randomized, open-label, two-treatment, two-period, two-cross-over study involving healthy volunteers aged 18 to 55 years. Participants are randomly assigned to receive either the test product or the reference product via intravenous injection at a dose of 100 mg elemental iron 2 mL administered continuously over 1 minute on an empty stomach after fasting for at least 10 hours. A standardized dinner is provided the night before dosing. Both groups follow the same dosing schedule and administration method. The study includes two treatment periods, and participants receive both products in a cross-over manner according to the protocol. During the study, blood samples are collected at multiple time points before and up to 96 hours after dosing to measure pharmacokinetic parameters such as peak plasma concentration and area under the curve for total iron and transferrin-bound iron in serum. Safety evaluations, including monitoring of adverse events, are conducted, especially on Day 5. The overall participation period covers screening, dosing, sample collection, and safety follow-up, with careful monitoring of vital signs, laboratory tests, and electrocardiograms to assess participant health and treatment effects.

Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants Under Fasting Conditions