{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T16:58:49Z","timestamp":1765817929856,"version":"3.48.0"},"reference-count":32,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,11,29]],"date-time":"2025-11-29T00:00:00Z","timestamp":1764374400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["bpspubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacology Res &amp;amp; Perspec"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Budesonide is a first\u2010line inhaled glucocorticoid (ICS) for asthma treatment in adults and children. The purpose of this study was to compare the pharmacokinetics and assess the bioequivalence between two budesonide pressurized metered\u2010dose inhalers (pMDIs, 200\u2009\u03bcg\/actuation\u2009\u00d7\u20091 actuation) in healthy Chinese subjects. The study was conducted in 32 healthy Chinese subjects using a single\u2010center, randomized, open\u2010label, four\u2010period and crossover design with a 3\u2010day washout between periods. Blood samples were collected up to 16\u2009h post\u2010dose. Plasma concentrations of budesonide were quantified using liquid chromatography\u2013tandem mass spectrometry (LC\u2013MS\/MS). Reference\u2010scaled average bioequivalence (RSABE) or average bioequivalence (ABE) method was applied to evaluate the bioequivalence, on the basis of the within\u2010subject standard deviation (\n                    <jats:italic>S<\/jats:italic>\n                    <jats:sub>WR<\/jats:sub>\n                    ) of the reference product (Budiair), and the safety was also assessed. Eventually, 31 subjects completed this study. For the maximum concentration (\n                    <jats:italic>C<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    ) (within\u2010subject standard deviation,\n                    <jats:italic>S<\/jats:italic>\n                    <jats:sub>WR<\/jats:sub>\n                    \u2009\u2265\u20090.294), the RSABE method showed a geometric mean ratio (GMR) of 97.13% with a 95% upper confidence bound of &lt;\u20090. For the area under plasma concentration\u2010time curve from time zero to the last measurable concentration (AUC\n                    <jats:sub>0\u2212t<\/jats:sub>\n                    ) and the area under plasma concentration\u2010time curve extrapolated to infinity (AUC\n                    <jats:sub>0\u2212\u221e<\/jats:sub>\n                    ) (\n                    <jats:italic>S<\/jats:italic>\n                    <jats:sub>WR<\/jats:sub>\n                    &lt;\u20090.294), ABE yielded GMRs of 104.81% and 104.61%, with 90% confidence intervals (CIs) of 99.98%\u2013109.86% and 99.81%\u2013109.63%, respectively. All adverse events (AEs) were mild to moderate and transient, with no serious adverse events (SAEs) reported. The two budesonide pMDIs (200\u2009\u03bcg) were bioequivalent and well tolerated in healthy Chinese subjects.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Trial Registration:<\/jats:bold>\n                    Chinese Clinical Trial Registry, Registration No. CTR20244600;\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                    identifier: NCT06924190\n                  <\/jats:p>","DOI":"10.1002\/prp2.70197","type":"journal-article","created":{"date-parts":[[2025,11,30]],"date-time":"2025-11-30T06:29:22Z","timestamp":1764484162000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Single Dose, Randomized, Open\u2010Label, Cross\u2010Over Bioequivalence Study of Budesonide Pressurized Metered\u2010Dose Inhaler in Healthy Chinese Subjects"],"prefix":"10.1002","volume":"13","author":[{"given":"Kai","family":"Huang","sequence":"first","affiliation":[{"name":"Drug Clinical Trial Institution, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi People's Hospital, Wuxi Medical Center, Nanjing Medical University  Wuxi China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shaohong","family":"Yin","sequence":"additional","affiliation":[{"name":"Lunan Better Pharmaceutical Co. LTD  Shandong China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Weiguo","family":"Huang","sequence":"additional","affiliation":[{"name":"Lunan Better Pharmaceutical Co. LTD  Shandong China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lairong","family":"Ding","sequence":"additional","affiliation":[{"name":"Lunan Better Pharmaceutical Co. LTD  Shandong China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wei","family":"Qin","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Institution, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi People's Hospital, Wuxi Medical Center, Nanjing Medical University  Wuxi China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhenzhong","family":"Qian","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Institution, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi People's Hospital, Wuxi Medical Center, Nanjing Medical University  Wuxi China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ying","family":"Ding","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Institution, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi People's Hospital, Wuxi Medical Center, Nanjing Medical University  Wuxi China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3380-8105","authenticated-orcid":false,"given":"Linling","family":"Que","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Institution, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi People's Hospital, Wuxi Medical Center, Nanjing Medical University  Wuxi China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yunfei","family":"Shi","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Institution, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi People's Hospital, Wuxi Medical Center, Nanjing Medical University  Wuxi China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jinxia","family":"Gao","sequence":"additional","affiliation":[{"name":"Lunan Better Pharmaceutical Co. LTD  Shandong China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yi","family":"Zhao","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Institution, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi People's Hospital, Wuxi Medical Center, Nanjing Medical University  Wuxi China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,11,29]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.3390\/jfmk9010015"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1183\/16000617.0193\u20102022"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.3390\/cells13050384"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.202312-2249SO"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.202312\u20102249SO"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/crj.12188"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0149\u20102918(03)80305\u20103"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.12669\/pjms.38.5.5749"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003495\u2010200868130\u201000005"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088\u2010200140060\u201000004"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.1036"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.585"},{"key":"e_1_2_11_14_1","unstructured":"National Medical Products Administration \u201cGuidelines for Bioequivalence Studies of Generic Oral Inhaled Products \u201dhttps:\/\/www.cde.org.cn\/zdyz\/downloadAtt?idCODE=77dd20dfcf61c41b2eb5b59e14bdd9dc."},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1208\/s12248\u2010015\u20109733\u20109"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.14055"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pupt.2018.03.001"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40268\u2010024\u201000464\u20108"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/j.1552\u20104604.1989.tb03329.x"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.xphs.2022.08.010"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.02111\u20102017"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1152\/ajplung.00319.2019"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaip.2022.05.026"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.202109\u20102205PP"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.5414\/CP202238"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtumed.2023.01.001"},{"key":"e_1_2_11_27_1","unstructured":"U.S. Food and Drug Administration \u201cDraft Guidance on Budesonide; Formoterol Fumarate Dihydrate \u201dhttps:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/psg\/PSG_021929.pdf."},{"key":"e_1_2_11_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pupt.2019.101873"},{"key":"e_1_2_11_29_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365\u20102125.2010.03857.x"},{"key":"e_1_2_11_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pupt.2018.08.001"},{"key":"e_1_2_11_31_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270008322122"},{"key":"e_1_2_11_32_1","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics14122667"},{"key":"e_1_2_11_33_1","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics15030983"}],"container-title":["Pharmacology Research &amp; Perspectives"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/prp2.70197","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T16:56:16Z","timestamp":1765817776000},"score":1,"resource":{"primary":{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/10.1002\/prp2.70197"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,29]]},"references-count":32,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2025,12]]}},"alternative-id":["10.1002\/prp2.70197"],"URL":"https:\/\/doi.org\/10.1002\/prp2.70197","archive":["Portico"],"relation":{},"ISSN":["2052-1707","2052-1707"],"issn-type":[{"type":"print","value":"2052-1707"},{"type":"electronic","value":"2052-1707"}],"subject":[],"published":{"date-parts":[[2025,11,29]]},"assertion":[{"value":"2025-04-23","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-10","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-29","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70197"}}