{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T17:03:16Z","timestamp":1783702996539,"version":"3.55.0"},"reference-count":18,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2025,8,28]],"date-time":"2025-08-28T00:00:00Z","timestamp":1756339200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,8,28]],"date-time":"2025-08-28T00:00:00Z","timestamp":1756339200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Clevidipine emulsion is an intravenous antihypertensive agent indicated for acute blood pressure control when oral therapies are contraindicated or ineffective. To address this gap in availability, a randomized, 2\u2010period, 2\u2010sequence crossover trial was conducted to evaluate the bioequivalence and safety of a generic clevidipine emulsion versus the reference product in 32 healthy Chinese adults. Participants received a 30\u2010minute intravenous infusion of 3\u00a0mg of clevidipine (test or reference formulation) in each study period, with serial blood samples collected from the contralateral arm relative to the infusion site for pharmacokinetic analysis. Treatment\u2010emergent adverse events (TEAEs) were monitored throughout the study. All participants completed both treatment phases. The generic formulation satisfied bioequivalence criteria for all primary pharmacokinetic parameters, with geometric mean ratios (90% confidence intervals) of C\n                    <jats:sub>max<\/jats:sub>\n                    , AUC\n                    <jats:sub>0\u2010t<\/jats:sub>\n                    , and AUC\n                    <jats:sub>0\u2010\u221e<\/jats:sub>\n                    fully contained within the 80%\u2010125% equivalence range. Three participants (9.4%) experienced mild TEAEs assessed as treatment\u2010related, including transient sinus tachycardia (n\u00a0=\u00a02) and asymptomatic alanine aminotransferase elevation (n\u00a0=\u00a01). The generic formulation met bioequivalence criteria and exhibited comparable safety profiles to the reference product.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.1591","type":"journal-article","created":{"date-parts":[[2025,8,28]],"date-time":"2025-08-28T09:19:35Z","timestamp":1756372775000},"page":"951-959","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Comparative Bioequivalence Study of 2 Clevidipine Formulations in Healthy Chinese participants: A Single\u2010Dose, 2\u2010Period Crossover Trial"],"prefix":"10.1002","volume":"14","author":[{"given":"Zhuo","family":"Chen","sequence":"first","affiliation":[{"name":"National Drug Clinical Trial Institution of West China Second Hospital Sichuan University  Chengdu China"},{"name":"NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation  Chengdu China"},{"name":"Key Laboratory of Birth Defects and Related Diseases of Women and Children Sichuan University Ministry of Education  Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fengshan","family":"Li","sequence":"additional","affiliation":[{"name":"National Drug Clinical Trial Institution of West China Second Hospital Sichuan University  Chengdu China"},{"name":"NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation  Chengdu China"},{"name":"Key Laboratory of Birth Defects and Related Diseases of Women and Children Sichuan University Ministry of Education  Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qin","family":"Yu","sequence":"additional","affiliation":[{"name":"National Drug Clinical Trial Institution of West China Second Hospital Sichuan University  Chengdu China"},{"name":"NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation  Chengdu China"},{"name":"Key Laboratory of Birth Defects and Related Diseases of Women and Children Sichuan University Ministry of Education  Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shiyin","family":"Feng","sequence":"additional","affiliation":[{"name":"National Drug Clinical Trial Institution of West China Second Hospital Sichuan University  Chengdu China"},{"name":"NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation  Chengdu China"},{"name":"Key Laboratory of Birth Defects and Related Diseases of Women and Children Sichuan University Ministry of Education  Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linrui","family":"Cai","sequence":"additional","affiliation":[{"name":"National Drug Clinical Trial Institution of West China Second Hospital Sichuan University  Chengdu China"},{"name":"NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation  Chengdu China"},{"name":"Key Laboratory of Birth Defects and Related Diseases of Women and Children Sichuan University Ministry of Education  Chengdu China"},{"name":"Shanghai First Biochemical Pharmaceutical Co., Ltd.  Minhang District Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Feng","family":"Hu","sequence":"additional","affiliation":[{"name":"National Drug Clinical Trial Institution of West China Second Hospital Sichuan University  Chengdu China"},{"name":"NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation  Chengdu China"},{"name":"Key Laboratory of Birth Defects and Related Diseases of Women and Children Sichuan University Ministry of Education  Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chunfeng","family":"Du","sequence":"additional","affiliation":[{"name":"National Drug Clinical Trial Institution of West China Second Hospital Sichuan University  Chengdu China"},{"name":"NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation  Chengdu China"},{"name":"Key Laboratory of Birth Defects and Related Diseases of Women and Children Sichuan University Ministry of Education  Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaohong","family":"Liu","sequence":"additional","affiliation":[{"name":"National Drug Clinical Trial Institution of West China Second Hospital Sichuan University  Chengdu China"},{"name":"NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation  Chengdu China"},{"name":"Key Laboratory of Birth Defects and Related Diseases of Women and Children Sichuan University Ministry of Education  Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,8,28]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.annemergmed.2008.04.025"},{"key":"e_1_2_8_3_1","first-page":"105","article-title":"Intravenous clevidipine for management of hypertension","volume":"3","author":"Rivera A","year":"2010","journal-title":"Integr Blood Press Control"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s002280050594"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.anclin.2017.01.013"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.105.006569"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1213\/01.ane.0000281443.13712.b9"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.3389\/fchem.2022.861952"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jchromb.2020.122448"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40256-021-00494-6"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clineuro.2023.107644"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000018541"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-012-1260-3"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.2012.651126"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1527-3466.2004.tb00143.x"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1097\/PCC.0000000000002562"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.3171\/2022.11.PEDS22255"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1097\/00000542-200205000-00010"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2125.1999.00933.x"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1591","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.1591","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1591","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,31]],"date-time":"2026-01-31T12:37:51Z","timestamp":1769863071000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1591"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,28]]},"references-count":18,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2025,12]]}},"alternative-id":["10.1002\/cpdd.1591"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1591","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,28]]},"assertion":[{"value":"2025-04-01","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-07-14","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-08-28","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}