{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,21]],"date-time":"2025-10-21T00:48:19Z","timestamp":1761007699924,"version":"build-2065373602"},"reference-count":22,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,8,22]],"date-time":"2025-08-22T00:00:00Z","timestamp":1755820800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["bpspubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacology Res &amp;amp; Perspec"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>The objectives of this study were to compare the pharmacokinetics and safety profiles of the test (T) preparation (Ferric carboxymaltose injection, BrightGene Bio\u2010Medical 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\u2010center, randomized, open\u2010label, parallel\u2010group trial, the study enrolled 96 IDA patients who were randomly allocated (1:1) to receive a 500\u2009mg intravenous dose of either the T or R preparation. Post\u2010dose blood samples for pharmacokinetic analysis were collected at multiple time points, while any adverse events were documented. The pharmacokinetic results showed comparable serum concentration\u2010time curves between the two groups. The 90% confidence intervals for the geometric mean ratios of <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub>, AUC<jats:sub>0\u2212<jats:italic>t<\/jats:italic><\/jats:sub>, and AUC<jats:sub>0\u2212\u221e<\/jats:sub> of total serum iron and <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub>, AUC<jats:sub>0\u2212<jats:italic>t<\/jats:italic><\/jats:sub> of serum transferrin\u2010bound iron were within the predefined bioequivalence criterion of 80%\u2013125%, 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.<\/jats:p>","DOI":"10.1002\/prp2.70137","type":"journal-article","created":{"date-parts":[[2025,8,22]],"date-time":"2025-08-22T08:05:13Z","timestamp":1755849913000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Randomized, Open\u2010Label, Single\u2010Dose, Parallel\u2010Group Bioequivalence Study of Ferric Carboxymaltose Injection Under Fasting Conditions in Chinese Adult Subjects With Iron Deficiency Anemia"],"prefix":"10.1002","volume":"13","author":[{"given":"Fengyun","family":"Gong","sequence":"first","affiliation":[{"name":"Phase I Clinical Trial Laboratory, Wuhan Jinyintan Hospital, Tongji Medical College of Huazhong University of Science and Technology, Hubei Clinical Research Center for Infectious Diseases, Wuhan Research Center for Communicable Disease Diagnosis and Treatment, Chinese Academy of Medical Sciences, Joint Laboratory of Infectious Diseases and Health, Wuhan Institute of Virology and Wuhan Jinyintan Hospital, Chinese Academy of Sciences  Wuhan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0915-8336","authenticated-orcid":false,"given":"Shengling","family":"Hu","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Laboratory, Wuhan Jinyintan Hospital, Tongji Medical College of Huazhong University of Science and Technology, Hubei Clinical Research Center for Infectious Diseases, Wuhan Research Center for Communicable Disease Diagnosis and Treatment, Chinese Academy of Medical Sciences, Joint Laboratory of Infectious Diseases and Health, Wuhan Institute of Virology and Wuhan Jinyintan Hospital, Chinese Academy of Sciences  Wuhan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiandong","family":"Yuan","sequence":"additional","affiliation":[{"name":"BrightGene Bio\u2010Medical Technology Co., Ltd.  Suzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jianxin","family":"Song","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology  Wuhan China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,8,22]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1146\/annurev\u2010nutr\u2010062320\u2010112625"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjgast\u20102021\u2010000759"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tips.2021.05.001"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1039\/D3FO04644C"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/ejh.13345"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/jn\/137.3.683"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2021013472"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.3390\/medicines6030085"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/hem3.108"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0117383"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.foodchem.2018.06.018"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.3324\/haematol.2024.284967"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jddst.2023.105181"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/hdi.12560"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10924\u2010021\u201002052\u20102"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1055\/s\u20100031\u20101296304"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471\u20102326\u201011\u20104"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12185\u2010018\u20102400\u2010z"},{"issue":"7","key":"e_1_2_11_20_1","first-page":"16","article-title":"Interpretation of the Technical Guidelines for the Bioequivalence Study of Generic Chemical Drugs With Pharmacokinetics Parameters as the Final Evaluation Index","volume":"37","author":"Shi X.","year":"2016","journal-title":"Shanghai Medical&Pharmaceutical Journal"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcpt.13219"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1055\/s\u20100031\u20101296301"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2019.12.010"}],"container-title":["Pharmacology Research &amp; Perspectives"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/prp2.70137","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,20]],"date-time":"2025-10-20T17:07:12Z","timestamp":1760980032000},"score":1,"resource":{"primary":{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/10.1002\/prp2.70137"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,22]]},"references-count":22,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2025,10]]}},"alternative-id":["10.1002\/prp2.70137"],"URL":"https:\/\/doi.org\/10.1002\/prp2.70137","archive":["Portico"],"relation":{},"ISSN":["2052-1707","2052-1707"],"issn-type":[{"type":"print","value":"2052-1707"},{"type":"electronic","value":"2052-1707"}],"subject":[],"published":{"date-parts":[[2025,8,22]]},"assertion":[{"value":"2025-01-17","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-06-10","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-08-22","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70137"}}