Abstract
The objectives of this study were to compare the pharmacokinetics and safety profiles of the test (T) preparation (Ferric carboxymaltose injection, BrightGene Bio-Medical Technology Co. Ltd.) and reference (R) preparation (Ferinject, Vifor France) after intravenous injection in Chinese adult subjects with iron deficiency anemia (IDA) under fasting conditions. Conducted as a single-center, randomized, open-label, parallel-group trial, the study enrolled 96 IDA patients who were randomly allocated (1:1) to receive a 500 mg intravenous dose of either the T or R preparation. Post-dose blood samples for pharmacokinetic analysis were collected at multiple time points, while any adverse events were documented. The pharmacokinetic results showed comparable serum concentration-time curves between the two groups. The 90% confidence intervals for the geometric mean ratios of C(max), AUC(0-t), and AUC(0-∞) of total serum iron and C(max), AUC(0-t) of serum transferrin-bound iron were within the predefined bioequivalence criterion of 80%-125%, indicating bioequivalence between the T and R preparations under fasting conditions. There were no significant differences in the safety profile between the two groups. This study confirmed the bioequivalence of the T and R preparations under fasting conditions, along with good safety.