{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,27]],"date-time":"2026-01-27T00:48:00Z","timestamp":1769474880360,"version":"3.49.0"},"reference-count":18,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,9,12]],"date-time":"2025-09-12T00:00:00Z","timestamp":1757635200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,9,12]],"date-time":"2025-09-12T00:00:00Z","timestamp":1757635200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100018731","name":"Jiangsu Hengrui Medicine","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100018731","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    HR19042 is a novel, orally administered, targeted\u2010release formulation of the topically active corticosteroid budesonide, developed to release active drug within the terminal ileum and indicated to reduced estimated glomerular filtration rate loss in adults with primary immunoglobulin A nephropathy. This randomized, single\u2010dose, open\u2010label, six\u2010sequence, three\u2010treatment crossover trial aimed to explore the pharmacokinetic (PK) of HR19042 in comparison with two other budesonide targeted\u2010release formulations among healthy Chinese subjects. Plasma budesonide concentrations were measured via liquid chromatography with tandem mass spectrometry, and PK parameters were analyzed using non\u2010compartmental methods. Eighteen subjects successfully completed the trial. The median T\n                    <jats:sub>lag<\/jats:sub>\n                    and T\n                    <jats:sub>max<\/jats:sub>\n                    of HR19042 were 1.25 and 3.50 h shorter than those of Nefecon, respectively. The C\n                    <jats:sub>max<\/jats:sub>\n                    of HR19042 was approximately 1.9\u2010fold higher than that of Nefecon and 1.4\u2010fold higher than that of Budenofalk. Based on the AUC\n                    <jats:sub>0\u2010t<\/jats:sub>\n                    determination, the relative bioavailability (F) of HR19042 was approximately 136.93% relative to Nefecon and 129.68% relative to Budenofalk. In vitro, the dissolution of HR19042 occurred 30 min earlier than that of Nefecon in the intestinal buffer medium. In conclusion, both in vivo and in vitro findings suggest that HR19042 exhibits a faster absorption rate and higher oral bioavailability.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.1603","type":"journal-article","created":{"date-parts":[[2025,9,12]],"date-time":"2025-09-12T08:12:31Z","timestamp":1757664751000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Comparison of the Pharmacokinetics of Three Budesonide Formulations in Healthy Chinese Subjects"],"prefix":"10.1002","volume":"15","author":[{"given":"Tengrui","family":"Yin","sequence":"first","affiliation":[{"name":"Jiangsu Hengrui Pharmaceuticals Co., Ltd.  Shanghai People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jing","family":"Zou","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Personalized Drug Therapy Key Laboratory of Sichuan Province, Sichuan Academy of Medical Sciences &amp; Sichuan Provincial People's Hospital, School of Medicine University of Electronic Science and Technology of China  Chengdu People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mei","family":"Tang","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Personalized Drug Therapy Key Laboratory of Sichuan Province, Sichuan Academy of Medical Sciences &amp; Sichuan Provincial People's Hospital, School of Medicine University of Electronic Science and Technology of China  Chengdu People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mengchang","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Personalized Drug Therapy Key Laboratory of Sichuan Province, Sichuan Academy of Medical Sciences &amp; Sichuan Provincial People's Hospital, School of Medicine University of Electronic Science and Technology of China  Chengdu People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qiwen","family":"Han","sequence":"additional","affiliation":[{"name":"Jiangsu Hengrui Pharmaceuticals Co., Ltd.  Shanghai People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hao","family":"Jiang","sequence":"additional","affiliation":[{"name":"Jiangsu Hengrui Pharmaceuticals Co., Ltd.  Shanghai People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Huihui","family":"Hu","sequence":"additional","affiliation":[{"name":"Jiangsu Hengrui Pharmaceuticals Co., Ltd.  Shanghai People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiuyang","family":"Li","sequence":"additional","affiliation":[{"name":"Jiangsu Hengrui Pharmaceuticals Co., Ltd.  Shanghai People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yijue","family":"Wu","sequence":"additional","affiliation":[{"name":"Jiangsu Hengrui Pharmaceuticals Co., Ltd.  Shanghai People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuanyuan","family":"Huang","sequence":"additional","affiliation":[{"name":"Jiangsu Hengrui Pharmaceuticals Co., Ltd.  Shanghai People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lin","family":"He","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Personalized Drug Therapy Key Laboratory of Sichuan Province, Sichuan Academy of Medical Sciences &amp; Sichuan Provincial People's Hospital, School of Medicine University of Electronic Science and Technology of China  Chengdu People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,9,12]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2011.05.033"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ekir.2020.08.009"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1080\/1744666X.2023.2206119"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/iji.12561"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.2217\/frd\u20102021\u20100013"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2022.5368"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1415463"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-200443120-00003"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ekir.2023.11.026"},{"key":"e_1_2_11_11_1","unstructured":"Kinpeygo (budesonide) [European summary of product characteristics]. Bad Vilbel; STADA Arzneimittel AG; 2024. Accessed July 22 2024.https:\/\/www.ema.europa.eu\/documents\/product\u2010information\/kinpeygo\u2010epar\u2010product\u2010information_en.pdf"},{"key":"e_1_2_11_12_1","unstructured":"Tarpeyo (budesonide) [US prescribing information]. Stockholm; Calliditas Therapeutics AB; 2024. Accessed July 22 2024.https:\/\/www.tarpeyo.com\/prescribinginformation.pdf"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.kint.2022.09.017"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(23)01554-4"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S383138"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejps.2008.07.005"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1055\/a-1073-7653"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.semnuclmed.2011.10.004"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)30550-0"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1603","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.1603","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1603","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,24]],"date-time":"2026-01-24T14:23:32Z","timestamp":1769264612000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1603"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9,12]]},"references-count":18,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026,1]]}},"alternative-id":["10.1002\/cpdd.1603"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1603","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9,12]]},"assertion":[{"value":"2025-06-08","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-08-08","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-09-12","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e1603"}}