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, AUC0−t , and AUC0−∞ of total serum iron and C max, AUC0−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.
Keywords: bioequivalence, biosimilar, ferric carboxymaltose injection, iron deficiency anemia, pharmacokinetics
Uncorrected and corrected mean plasma concentration‐time profiles of total serum iron of T and R preparations.
1. Introduction
Iron serves as a key constituent of hemoglobin, cytochrome enzymes, and numerous reductase enzymes within the human body [1]. It plays a critical role in oxygen and carbon dioxide transport, as well as in redox and metabolic processes, making it indispensable for normal physiological functions [2, 3]. Insufficient iron intake depletes the body's iron reserves, resulting in iron deficiency anemia (IDA), which is often accompanied by symptoms such as fatigue, irritability, mood or cognitive impairments, and memory loss [4, 5]. These conditions severely affect overall health and reduce the quality of life. Iron deficiency in infants and preschool‐aged children can particularly hinder growth and development [6]. Diseases that affect iron metabolism may indirectly contribute to IDA, and treatment of IDA should address both the underlying condition and alleviate anemia symptoms to reduce the associated bodily harm [3, 7, 8]. The primary medications for treating IDA are divided into two categories: iron supplements and erythropoiesis‐stimulating agents, with iron supplements being the most widely used and fundamental treatment [9].
Oral iron supplements have been in use for a long time but often cause gastrointestinal side effects [10]. Free iron dissolved in gastric acid can produce active iron ions, which directly oxidize lipids and proteins in gastric and intestinal mucosal cells, causing inflammation, ulcers, and even hemorrhagic necrosis [11]. The absorption of iron is influenced by dietary factors, which may compromise its bioavailability [12, 13]. Furthermore, oral iron supplementation is slow‐acting, with prolonged treatment cycles that fail to meet the needs of patients requiring rapid iron replenishment [12]. To address this clinical need, researchers have developed intravenous iron formulations. These products are large molecular complexes consisting of iron cores encapsulated in polysaccharide shells [14]. Due to variations in the type of polysaccharide, the strength of iron binding and molecular size differ, leading to significant differences in the physicochemical properties, safety, and pharmacokinetics of these products [14, 15]. Within conventional parenteral iron supplementation modalities, dextran‐based formulations carry an elevated propensity for anaphylactoid reactions, whereas iron‐sucrose complexes and gluconate‐stabilized preparations exhibit dose‐dependent tolerability constraints that necessitate restrictive infusion protocols [14, 16]. Therefore, novel intravenous iron preparations that are both safe and capable of delivering high doses rapidly are urgently needed in clinical practice.
Ferric carboxymaltose has demonstrated higher efficacy and a lower incidence of adverse reactions in the treatment of IDA, meeting the clinical demand for large‐dose, rapid iron administration [17, 18]. As a result, ferric carboxymaltose has become a representative drug in the category of novel intravenous iron agents.
In this study, a single‐center, randomized, open‐label, single‐dose, parallel‐group phase I clinical trial was conducted to evaluate the bioequivalence in pharmacokinetics and safety between the test (T) and reference (R) preparations in subjects with IDA under fasting conditions, in order to actively fill the gap in the domestic drug market and provide safer and more effective drug choices for the majority of patients with IDA.
2. Methods
2.1. Study Subjects
This single‐center, randomized, open‐label, single‐dose, parallel‐group trial enrolled Chinese adult subjects with iron deficiency anemia. The inclusion criteria were as follows: (1) Chinese adults aged 18–50 years (including 18 and 50 years), both male and female. (2) Male weight ≥ 50 kg, female weight ≥ 45 kg and body mass index (BMI) of 18 to 30 kg/m2 (including the boundary values). (3) Iron deficiency anemia was defined as follows: (1) 19 g/dL ≤Hb < 11 g/dL (female) or 9 g/dL ≤ Hb < 12 g/dL (male); (2) serum ferritin≤100 ng/mL; (3) physical examination, vital signs measurement, laboratory, and other auxiliary examination results showed normal or the researcher judged that the abnormality had no clinical significance; (4) subjects (including partners) have taken effective contraceptive measures within 14 days before screening and subjects should be willing to take effective contraceptive measures from the date of screening to 3 months after the end of the study. Participants meeting any of the following criteria were excluded: (1) History of allergies, especially to iron, maltose or its analogues or other components of the investigational drug. (2) In addition to iron deficiency anemia, any other diseases that may influence the results of the study were combined within 6 months before screening. (3) Glomerular filtration rate < 60 mL/min/1.73 m2. (4) Suffered from iron storage diseases, such as hemochromatosis or conditions affecting iron utilization, such as iron‐refractory anemia or hemoglobin disease such as thalassemia or symptomatic anemia requiring red blood cell transfusion or undergoing hemodialysis. (5) Subjects who had intravenous iron therapy within 6 months before screening, had a history of erythropoietin stimulation therapy and/or blood transfusion within 4 weeks before screening, and had used any prescription drug, over‐the‐counter drug, traditional Chinese medicine or health care product within 7 days before screening. (6) History of alcohol, drug or substance abuse, (7) Smoking > 5 cigarettes daily, (8) Blood donation or significant blood loss exceeding 400 mL or use of blood products within 3 months before screening. (9) Participation in other clinical trials within the past 3 months. (10) Vaccination within 2 weeks before screening or had vaccination plans during the trial. (11) Pregnancy or lactation. (12) Any other factors deemed inappropriate for trial inclusion by the investigator.
2.2. Study Design and Procedures
The study was executed at the phase I clinical trial laboratory of Wuhan Infectious Disease Hospital, adhering to the principles of the Declaration of Helsinki, the International Conference on Harmonization Standards for Good Clinical Practice, and drug registration regulations issued by the National Medical Products Administration (NMPA). Ethical approval was obtained from the Ethics Committee of Wuhan Infectious Disease Hospital before the start of the trial (ethical approval no. GCP‐ICT‐2023‐09.18, ethical approval date: 18 September 2023) and was registered at the NMPA (CTR20233680). Informed consent was obtained from all patients before any research procedures.
A random table, generated by SAS version 9.4 using a stratified block randomization method, will determine subjects who received the T or R preparation. Screening qualified subjects, first stratified according to weight, weight < 60 kg into the A layer, weight ≥ 60 kg into the B layer, and ensuring that each layer selected several multiples of four. The subjects were randomly assigned to the test drug group or the reference preparation group according to a ratio of 1:1.
Subjects were administered an intravenous injection of 500 mg (10 mL) of the T preparation (Ferric carboxymaltose injection, BrightGene Bio‐Medical Technology Co. Ltd.) or R preparation (Ferinject, Vifor France) under fasting conditions, with an infusion time of 5 ± 0.25 min. Around 4 h and 10 h post‐administration, subjects were provided with standardized lunch and dinner that were low in iron content. The experimental procedure schedule was shown in Table S1.
2.3. Pharmacokinetics Analysis
Blood samples for pharmacokinetics (PK) analysis were collected by direct venipuncture or a forearm venous indwelling catheter, and the blood collection arm should be a non‐venous injection arm. Baseline data blood samples were collected 1 day before administration (D −1). Venous blood was collected at 8:00 and 20:00 on the same day. On the day of administration (D 1), venous blood was collected at 0 h (within 60 min before administration) and 2.5, 5 min (immediately after administration), 10, 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 h after administration. Venous blood samples (2.5 mL) were collected into additive‐free vacuum tubes following standardized protocols. Post‐collection processing involved refrigerated centrifugation (2°C–8°C, 500 g, 10 min), with prompt serum isolation within 90 min of phlebotomy. Aliquot specimens underwent ultra‐low temperature preservation (−60°C) in cryovials until batch analysis.
Concentrations of total serum iron and serum transferrin‐bound iron were measured using a fully validated inductively coupled plasma mass spectrometry (ICP‐MS, ICAP‐RQ, Thermo Fisher) method. The quantitative range of total serum iron and serum transferrin‐bound iron was 0.5–300 μg/mL and 0.9–9.5 μg/mL, respectively.
The PK parameters of total serum iron and serum transferrin‐bound iron after ferric carboxymaltose administration were calculated using a noncompartmental analysis, including maximum serum concentration (C max) and area under the serum concentration–time curve (AUC) from time zero to last measurable concentration (AUC0–t ), and AUC from time zero to infinite time (AUC0−∞). Parameters were time to reach C max (T max), mean residence time (MRT), elimination rate constant (λz) and terminal elimination half‐life (t 1/2). PK analysis covered all enrolled subjects.
2.4. Safety Evaluation
Safety evaluations involved physical examinations, standard 12‐lead electrocardiograms (ECGs), and clinical laboratory tests including routine blood tests, urinalysis, urine pregnancy tests for women, hepatic function, renal function, and coagulation function tests.
2.5. Statistical Analysis
The statistical analysis was performed using SAS version 9.4 (SAS Institute Inc., Cary, NC, USA). PK parameters were calculated and assessed with Phoenix WinNonlin version 8.4 (Pharsight Corp., Mountain View, CA, USA) via noncompartmental analysis. The C max, AUC0−t , and AUC0−∞ were logarithmically converted for analysis of variance (ANOVA). Linear and semi‐log graphs were used to evaluate the mean concentration‐time curve. Log‐transformed values (In) of AUC0−t , AUC0−∞, and C max for the two formulations were estimated using an ANOVA procedure. PK parameter data from all subjects were utilized for bioequivalence evaluation. The 90% confidence interval (CI) of the geometric mean ratio (T preparation versus R preparation) of the main index was calculated. Bioequivalence between the two formulations was considered if the 90% CI fell within the range of 80%–125%. The bioequivalence results before and after baseline correction were provided, and the data after baseline correction were used for bioequivalence evaluation. A two‐one‐sided t‐test at α = 0.05 was applied to test AUC0−t and C max equivalence between the T and R formulations.
3. Results
3.1. Subjects
In this study, a total of 216 subjects were screened, 96 subjects were planned to be enrolled, and 96 subjects were actually enrolled. All 96 subjects completed all the tests according to the requirements of the program. No subjects fell off, and no subjects were excluded in the whole experiment. There was no significant difference in age, height, weight, and BMI among the subjects in each group. Demographic and other baseline characteristics of the subjects are detailed in Table S2.
3.2. Pharmacokinetics Analysis
The mean plasma concentration–time profiles of total serum iron and serum transferrin‐bound iron were comparable for T and R preparations, as shown in Figures 1 and 2, respectively. The PK parameters of total serum iron and serum transferrin‐bound iron after intravenous injection of T and R preparations were summarized in Tables 1 and 2, respectively. The bioequivalence evaluation results of total serum iron and serum transferrin‐bound iron after intravenous injection of T and R preparations were presented in Tables 3 and 4, respectively. The 90% CI of the geometric mean ratio (GMR) of C max, AUC0−t , and AUC0−∞ of total serum iron in 96 subjects before and after baseline correction were completely within the acceptable bioequivalence range (80%–125%). The 90% CI of the GMR of C max and AUC0−t of serum transferrin‐bound iron fell within the equivalent range of 80%–125%. With 80% and 125% as the low and high limits of the bioequivalence test, C max, AUC0−t , and AUC0−∞ were tested by a two‐way one‐sided t‐test. The p values were less than 0.05; that is, the one‐sided t‐test in both directions could be confirmed by a 95% confidence interval. The T preparation and the R preparations were bioequivalent under fasting conditions.
FIGURE 1.
(A) Uncorrected mean plasma concentration (±SD)–time curve of total serum iron (linear coordinate). (B) Uncorrected mean plasma concentration (±SD)–time curve of total serum iron (semilogarithmic coordinate). (C) Corrected mean plasma concentration (±SD)–time curve of total serum iron (linear coordinate). (D) Corrected mean plasma concentration (±SD)–time curve of total serum iron (semilogarithmic coordinate). R, reference group; SD, standard deviation; T, test group.
FIGURE 2.
(A) Uncorrected mean plasma concentration (±SD)–time curve of serum transferrin‐bound iron (linear coordinate). (B) Uncorrected mean plasma concentration (±SD)–time curve of serum transferrin‐bound iron (semilogarithmic coordinate). R, reference group; SD, standard deviation; T, test group.
TABLE 1.
PK parameters of T and R preparation of total serum iron.
| PK parameters | Mean ± SD (CV%) | |||
|---|---|---|---|---|
| Uncorrected | Corrected | |||
| R | T | R | T | |
| T max a (h) | 0.17 (0.09, 0.75) (53.26) | 0.17 (0.09, 1.00) (88.64) | 0.17 (0.09, 0.75) (53.26) | 0.17 (0.09, 1.00) (88.64) |
| C max (μg/mL) | 220.06 ± 34.34 (15.60) | 215.58 ± 30.89 (14.33) | 219.789 ± 34.2639 (15.59) | 215.29 ± 30.86 (14.34) |
| AUC0−t (μg·h/mL) | 3975.72 ± 730.47 (18.37) | 3951.88 ± 730.85 (18.49) | 3956.39 ± 727.72 (18.39) | 3930.82 ± 726.12 (18.47) |
| AUC0−∞ (μg·h/mL) | 4042.59 ± 740.16 (18.31) | 4019.81 ± 751.66 (18.70) | 4018.19 ± 737.43 (18.35) | 3992.51 ± 745.19 (18.66) |
| MRT0−t (h) | 15.46 ± 1.20 (7.74) | 15.60 ± 1.49 (9.57) | 15.36 ± 1.24 (8.07) | 15.49 ± 1.48 (9.58) |
| λz (1/h) | 0.06 ± 0.08 (12.89) | 0.06 ± 0.01 (13.49) | 0.06 ± 0.01 (14.97) | 0.06 ± 0.01 (13.28) |
| t 1/2 (h) | 11.79 ± 1.48 (12.58) | 11.82 ± 1.53 (12.98) | 11.60 ± 1.60 (13.79) | 11.59 ± 1.50 (12.96) |
Abbreviations: AUC0–∞, area under the plasma concentration–time curve from time zero to infinite time; AUC0–t , area under the plasma concentration–time curve from time zero to the last measurable concentration; C max, maximum plasma concentration; CV, coefficient of variation; MRT, mean residence time; PK, pharmacokinetics; R, the reference preparation; SD, standard deviation; T, the test preparation; t 1/2, terminal elimination half‐life; T max, time to reach maximum plasma concentration; λz, elimination rate constant.
T max was represented as median (minimum, maximum). V d was calculated by the area method.
TABLE 2.
PK Parameters of T and R preparation of serum transferrin‐binding iron.
| PK parameters | Mean ± SD (CV%) (uncorrected a ) | |
|---|---|---|
| T | R | |
| T max a (h) | 6.00 (0.09, 48.01) (100.71) | 7.01 (0.75, 24.01) (67.33) |
| C max (μg/mL) | 3.81 ± 0.78 (20.45) | 3.69 ± 0.64 (17.25) |
| AUC0−t (μg·h/mL) | 192.97 ± 45.58 (23.62) | 190.02 ± 43.34 (22.81) |
| AUC0−∞ (μg·h/mL) | 814.00 ± 770.18 (94.62) | 678.19 ± 481.06 (70.93) |
| MRT0−t (h) | 30.49 ± 5.37 (17.62) | 30.66 ± 5.46 (17.81) |
| λz (1/h) | 0.01 ± 0.01 (72.29) | 0.01 ± 0.01 (63.33) |
| t 1/2 (h) | 155.61 ± 151.47 (97.34) | 132.87 ± 105.49 (79.39) |
Abbreviations: AUC0–∞, area under the plasma concentration–time curve from time zero to infinite time; AUC0–t , area under the plasma concentration–time curve from time zero to the last measurable concentration; C max, maximum plasma concentration; CV, coefficient of variation; MRT, mean residence time; PK, pharmacokinetics; R, the reference preparation; SD, standard deviation; T, the test preparation; t 1/2, terminal elimination half‐life, T max, time to reach maximum plasma concentration; λz, elimination rate constant.
As the baseline concentration of serum transferrin‐bound iron is BQL, only the baseline‐corrected average PK parameters of total serum iron are provided. T max was represented as median (minimum, maximum). V d was calculated by the area method.
TABLE 3.
Bioequivalence analysis of T and R preparation of total serum iron.
| PK parameters | GMR | 90% CI (%) | ||
|---|---|---|---|---|
| T | R | (T/R) (%) | ||
| Corrected | ||||
| C max (μg/mL) | 213.17 | 217.19 | 98.15 | 93.31–103.24 |
| AUC0−t (μg·h/mL) | 3867.20 | 3891.46 | 99.38 | 93.39–105.75 |
| AUC0−∞ (μg·h/mL) | 3926.67 | 3952.75 | 99.34 | 93.34–105.73 |
| Uncrrected | ||||
| C max (μg/mL) | 213.47 | 217.45 | 98.17 | 93.33–103.26 |
| AUC0−t (μg·h/mL) | 3887.67 | 3910.54 | 99.42 | 93.41–105.80 |
| AUC0−∞ (μg·h/mL) | 3953.15 | 3976.95 | 99.40 | 93.39–105.80 |
Abbreviations: AUC0–∞, area under the plasma concentration–time curve from time zero to infinite time; AUC0–t , area under the plasma concentration–time curve from time zero to the last measurable concentration; CI, confidence interval; C max, maximum plasma concentration; GMR, geometric mean and ratio; PK, pharmacokinetics; R, the reference preparation; T, the test preparation.
TABLE 4.
Bioequivalence analysis of T and R preparations of serum transferrin‐bound iron.
| PK parameters | GMR | 90% CI (%) | ||
|---|---|---|---|---|
| T | R | (T/R) (%) | ||
| Uncorrected a | ||||
| C max (μg/mL) | 3.64 | 3.75 | 97.17 | 91.81–102.84 |
| AUC0−t (μg·h/mL) | 184.28 | 187.30 | 98.39 | 90.10–107.43 |
| AUC0−∞ (μg·h/mL) | 555.65 | 637.42 | 87.17 | 69.80–108.87 |
Abbreviations: AUC0–∞, area under the plasma concentration–time curve from time zero to infinite time; AUC0–t , area under the plasma concentration–time curve from time zero to the last measurable concentration; CI, confidence interval; C max, maximum plasma concentration; GMR, geometric mean and ratio; PK, pharmacokinetics; R, the reference preparation; T, the test preparation.
As the baseline concentration of serum transferrin‐bound iron is BQL, only the baseline‐corrected average PK parameters of total serum iron are provided.
3.3. Safety Assessments
Out of the 164 subjects included, 64 subjects (66.7%) experienced a total of 105 adverse events (AEs) (Table S3). A total of 58 subjects (60.4%) experienced 81 instances of adverse reactions (Table S4).
A total of 57 AEs occurred in 33 patients (68.8%) who received intravenous injection of the T preparation. Among them, 51 AEs were grade 1 (mild), 6 AEs were grade 2 (moderate), and no serious AEs occurred. The relationship between AEs and drugs was that 44 cases may be related and 13 cases may not be related. The outcome of AEs was 45 cases of complete recovery, 11 cases of stable recovery, and 1 case of loss of follow‐up. A total of 44 adverse reactions occurred in 31 subjects (64.6%).
A total of 48 AEs occurred in 31 subjects (64.6%) who received intravenous injection of the R preparation. Among them, 48 cases of AEs were all grade 1 (mild), and no serious AEs occurred. The relationship between AEs and drugs was 37 cases that may be related and 11 cases that may not be related. The outcome of AEs was 34 cases of complete recovery, 10 cases of stable recovery, and 4 cases of loss of follow‐up. A total of 37 adverse reactions occurred in 27 subjects (56.3%).
The overall incidence of adverse reactions of T and R preparation was comparable. No serious AEs were reported, and no subjects withdrew from the trial due to AEs. The adverse reactions with high frequency after intravenous injection of ferric carboxymaltose injection in Chinese adult subjects with IDA were decreased blood phosphorus and decreased lymphocyte count, and the severity was grade 1 (mild).
4. Discussion
This single‐center, randomized, open‐label, single‐dose, parallel‐group trial aimed to demonstrate the bioequivalence and safety of T and R preparations after intravenous injection in Chinese adult subjects with IDA under fasting conditions.
Serum iron follows a circadian rhythm; collecting initial iron profiles at precise time points is crucial. The study design adhered to the technical guidelines for the bioequivalence study of generic chemical drugs with pharmacokinetic parameters as the final evaluation index [19]. The baseline correction requirements for endogenous compounds with cycle specificity need to be determined according to the pharmacokinetic characteristics of multiple points before administration. The baseline value is subtracted from the corresponding baseline value of the blood concentration after administration. At the same time, considering the requirements of the absorption phase, the peak concentration near and the elimination phase, and referring to the setting of blood collection points in relevant literature [18, 20, 21, 22] the blood collection points of the study were comprehensively designed.
This study showed that the maximum inter‐individual variation coefficient of C max, AUC0−t , and AUC0‐∞ of serum total iron after baseline correction of the T preparation and the R preparation was 18.66% (AUC0−t ). The PASS software was used to verify the reliability and scientificity of the sample size design. The results showed that when the type I error rate α = 0.05, the degree of certainty 1−β = 80%, and the true ratio took the minimum value (98.15%), a certain shedding rate was considered. The actual enrollment of 96 subjects in the fasting test met the test sample size requirements.
This study is an open design, which may lead to selectivity, evaluation, and test bias. In order to objectively detect the blood drug concentration, the label on the cryopreserved blood vessel does not reflect the type of test drug (T or R preparation) injected by the subject in a single intravenous injection. The detection and analysis personnel use blind state analysis, which does not know the subject's dosage during the analysis process, to eliminate the possible bias in the sample test process.
In this study, the 90% CI of C max, AUC0−t , and AUC0−∞ GMR of total serum iron in 96 subjects before baseline correction were 3.33%–103.26%, 93.41%‐105.80%, and 93.39%–105.80%, respectively. After baseline correction, the GMR of C max, AUC0−t , and AUC0−∞ of total serum iron were detected, and the 90% CI of GMR was 93.31%–103.24%, 93.39%–105.75% and 93.34%–105.73%, respectively, which were all within the acceptable range of bioequivalence. The above analysis results showed that the bioequivalence conclusion of T preparation and R preparation was established.
A total of 57 AEs occurred in 33 patients (68.8%) receiving intravenous T preparation. Among them, 51 AEs were grade 1 (mild) and 6 AEs were grade 2 (moderate). A total of 48 AEs occurred in 31 subjects (64.6%) who received intravenous injection of the R preparation. Among them, 48 cases of AEs were all grade 1 (mild). While higher AEs were observed with T preparation compared to R preparation, the current sample size provides limited statistical power to conclusively characterize safety differences. Importantly, all reported AEs were mild to moderate in severity and no serious AEs or new safety signals were identified. In the future, multicenter, prospective cohort studies are needed to compare the differences in the incidence of AE between the two preparations in the real‐world population, as well as safety monitoring of the products. Overall, the T and R preparations are safe under fasting conditions.
5. Conclusions
In conclusion, in this phase I clinical trial, which employed single‐center, randomized, open, single‐dose, parallel design, T and R preparations demonstrated bioequivalence and exhibited favorable safety profiles after intravenous injection in adult Chinese volunteers with IDA under fasting conditions. These findings support the T preparations as a therapeutic alternative to the R preparations.
Author Contributions
All authors contributed to the study conception and design. Fengyun Gong and Jiandong Yuan recruited the patients, collected the data, and were responsible for the statistical analysis. Shengling Hu, Fengyun Gong, and Jianxin Song were involved in writing the manuscript. All authors contributed to the article and approved the submitted version.
Ethics Statement
The study was executed at the phase I clinical trial laboratory of Wuhan Infectious Disease Hospital, adhering to the principles of the Declaration of Helsinki, the International Conference on Harmonization Standards for Good Clinical Practice and drug registration regulations issued by the National Medical Products Administration (NMPA). Ethical approval was obtained from the Ethics Committee of Wuhan Infectious Disease Hospital before the start of the trial. (ethical approval no. GCP‐ICT‐2023‐09.18, ethical approval date: 18 September 2023) and was registered at the NMPA (CTR20233680).
Consent
Informed consent was obtained from all patients before any research procedures.
Conflicts of Interest
Jiandong Yuan is an employee of BrightGene Bio‐Medical Technology Co., Ltd., Suzhou, China.
Supporting information
Data S1.
Gong F., Hu S., Yuan J., and Song J., “A Randomized, Open‐Label, Single‐Dose, Parallel‐Group Bioequivalence Study of Ferric Carboxymaltose Injection Under Fasting Conditions in Chinese Adult Subjects With Iron Deficiency Anemia,” Pharmacology Research & Perspectives 13, no. 5 (2025): e70137, 10.1002/prp2.70137.
Funding: This research was funded by BrightGene Bio‐Medical Technology Co., Ltd., Suzhou, China.
Fengyun Gong and Shengling Hu contributed equally to this work.
Data Availability Statement
The datasets used in this study can be obtained from the corresponding author upon request.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data S1.
Data Availability Statement
The datasets used in this study can be obtained from the corresponding author upon request.