{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T02:21:39Z","timestamp":1778811699004,"version":"3.51.4"},"reference-count":20,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2024,9,5]],"date-time":"2024-09-05T00:00:00Z","timestamp":1725494400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>This single\u2010center, randomized, open, two\u2010preparation, single\u2010dose, two\u2010period, self\u2010crossover trial aimed to assess the bioequivalence and safety of the test (T) preparation compared to the reference (R) preparation following intravenous injection in healthy subjects under fasting conditions. Twenty\u2010four healthy subjects were enrolled in the study and subjects were randomly divided into two groups at a 1:1 ratio and were administered once per period, with an 8\u2010day washout period. During each period, serum drug concentrations were detected for pharmacokinetic analysis and adverse events were recorded for safety analysis. The 90% confidence intervals for the geometric mean ratios (T:R) of maximum serum concentration, area under the serum concentration\u2010time curve from time zero to the last measurable concentration, and area under the serum concentration\u2010time curve from time zero to infinite time fell within the predefined bioequivalence range of 80%\u2010125%, indicating bioequivalence between the T and R preparation under fasting conditions. Additionally, four subjects (16.7%) experienced five instances of adverse events in the T group, while five subjects (21.7%) experienced five instances of adverse events in the R group. This trial indicated the potential bioequivalence between the T and R products under fasting conditions, based on pharmacokinetic and safety profile.<\/jats:p>","DOI":"10.1002\/cpdd.1467","type":"journal-article","created":{"date-parts":[[2024,9,5]],"date-time":"2024-09-05T11:46:07Z","timestamp":1725536767000},"page":"1339-1344","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Bioequivalence of Meloxicam Nanocrystal Injection in Healthy Chinese Volunteers"],"prefix":"10.1002","volume":"13","author":[{"given":"Shengling","family":"Hu","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"}]},{"given":"Xia","family":"Liu","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":"Qinghua","family":"Wan","sequence":"additional","affiliation":[{"name":"CSPC Zhongqi Pharmaceutical Technology (SJZ) Co., Ltd.  Shijiazhuang China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xueyuan","family":"Zhang","sequence":"additional","affiliation":[{"name":"CSPC Zhongqi Pharmaceutical Technology (SJZ) Co., Ltd.  Shijiazhuang China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fengyun","family":"Gong","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"}]}],"member":"311","published-online":{"date-parts":[[2024,9,5]]},"reference":[{"issue":"1","key":"e_1_2_8_2_1","first-page":"1","article-title":"Pathology of pain and its implications for therapeutic interventions","volume":"9","author":"Cao B","year":"2024","journal-title":"Signal Transduct Target Ther"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijerph20043064"},{"issue":"1","key":"e_1_2_8_4_1","article-title":"Knowledge about postoperative pain and its management in surgical patients","volume":"12","author":"Nasir M","journal-title":"Cureus"},{"issue":"4","key":"e_1_2_8_5_1","article-title":"Pain management of acute and chronic postoperative pain","volume":"14","author":"Ishida Y","journal-title":"Cureus"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1517\/17425255.1.4.739"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-199651030-00007"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.6.12.2117"},{"issue":"3","key":"e_1_2_8_9_1","first-page":"253","article-title":"Clinical pharmacokinetics of meloxicam","volume":"47","author":"T\u00fcrck D","year":"1997","journal-title":"Arzneimittelforschung"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijpharm.2009.07.009"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1615\/CritRevTherDrugCarrierSyst.2024048988"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijpharm.2014.08.022"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.2217\/pmt-2020-0082"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.2147\/JPR.S149879"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.666"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1097\/GOX.0000000000001846"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1213\/ANE.0000000000003920"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.1058"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S418730"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.2165\/00044011-200222120-00001"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-199936020-00003"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1467","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,12,2]],"date-time":"2024-12-02T02:25:38Z","timestamp":1733106338000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1467"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,9,5]]},"references-count":20,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2024,12]]}},"alternative-id":["10.1002\/cpdd.1467"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1467","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,9,5]]},"assertion":[{"value":"2024-07-08","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-08-16","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-09-05","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}