{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,11,2]],"date-time":"2023-11-02T06:10:11Z","timestamp":1698905411977},"reference-count":10,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2023,5,29]],"date-time":"2023-05-29T00:00:00Z","timestamp":1685318400000},"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":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Celecoxib is a sulfanilamide nonsteroidal anti\u2010inflammatory drug that can selectively inhibit cyclooxygenase\u20102 to inhibit prostaglandin production, achieving anti\u2010inflammatory and analgesic effects. This study investigated the pharmacokinetics, safety, and bioequivalence of a single oral dose of celecoxib capsule (the test or reference preparation) in healthy volunteers under fasting and fed conditions. A single\u2010center, randomized, open, single\u2010dose, double\u2010cycle crossover self\u2010control design was conducted: 40 healthy volunteers were enrolled in the fasting and fed groups, respectively. A completely randomized method was used, with one group taking the test celecoxib preparation (T) and the other taking the reference celecoxib preparation (R). During the administration period, the safety of the drug was evaluated simultaneously, and venous blood was collected at the corresponding time points. The concentration of celecoxib in plasma was measured by liquid chromatography\u2013tandem mass spectrometry. The main pharmacokinetic parameters were logarithmically converted and analyzed for variance. The 90% confidence interval for the bioavailability of the T compared to the R was calculated using maximum drug plasma concentration, area under the plasma concentration\u2013time curve from time zero to the last quantifiable concentration point, and area under the plasma concentration\u2013time curve from time zero to infinity for a single oral dose in volunteers, and the data obtained were all between 80% and 125%, indicating that the T and R have bioequivalence and good safety during fasting and fed administration.<\/jats:p>","DOI":"10.1002\/cpdd.1270","type":"journal-article","created":{"date-parts":[[2023,5,29]],"date-time":"2023-05-29T06:19:01Z","timestamp":1685341141000},"page":"1069-1075","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Bioequivalence of Celecoxib Capsules in Chinese Healthy Volunteers"],"prefix":"10.1002","volume":"12","author":[{"given":"Lichun","family":"Dong","sequence":"first","affiliation":[{"name":"Yunnan Provincial Hospital of Traditional Chinese Medicine  Kunming China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mingxuan","family":"Zhao","sequence":"additional","affiliation":[{"name":"Yunnan Provincial Hospital of Traditional Chinese Medicine  Kunming China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Huiyuan","family":"Huang","sequence":"additional","affiliation":[{"name":"Yunnan Provincial Hospital of Traditional Chinese Medicine  Kunming China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Runfang","family":"Guan","sequence":"additional","affiliation":[{"name":"Yunnan Provincial Hospital of Traditional Chinese Medicine  Kunming China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ruixia","family":"Li","sequence":"additional","affiliation":[{"name":"Yunnan Provincial Hospital of Traditional Chinese Medicine  Kunming China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuxin","family":"Fan","sequence":"additional","affiliation":[{"name":"Yunnan Provincial Hospital of Traditional Chinese Medicine  Kunming China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jin","family":"Feng","sequence":"additional","affiliation":[{"name":"Yunnan Provincial Hospital of Traditional Chinese Medicine  Kunming China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Juan","family":"Zhang","sequence":"additional","affiliation":[{"name":"Yunnan Provincial Hospital of Traditional Chinese Medicine  Kunming China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wenhong","family":"Zou","sequence":"additional","affiliation":[{"name":"Yunnan Provincial Hospital of Traditional Chinese Medicine  Kunming China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiong","family":"Chen","sequence":"additional","affiliation":[{"name":"Yunnan Provincial Hospital of Traditional Chinese Medicine  Kunming China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shuxian","family":"Long","sequence":"additional","affiliation":[{"name":"Yunnan Provincial Hospital of Traditional Chinese Medicine  Kunming China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jianchang","family":"He","sequence":"additional","affiliation":[{"name":"Yunnan Provincial Hospital of Traditional Chinese Medicine  Kunming China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,5,29]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1021\/jm9700225"},{"issue":"9","key":"e_1_2_7_3_1","article-title":"Single dose oral analgesics for acute postoperative pain in adults \u2013 an overview of Cochrane reviews","volume":"2015","author":"Moore R","year":"2015","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMc1702562"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1611593"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0090-6980(98)00064-1"},{"key":"e_1_2_7_7_1","first-page":"S617","article-title":"SC\u201058635 (celecoxib): a highly selective inhibitor of cyclooxygenase\u20102. Disposition kinetics in man and identification of its major CYP450 isozyme in its biotransformation","volume":"11","author":"Karim A","year":"1997","journal-title":"Pharm Res"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(10)60673-3"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-07-0336"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejpb.2009.05.009"},{"issue":"2","key":"e_1_2_7_11_1","first-page":"638","article-title":"Pharmacokinetics of celecoxib after oral administration in dogs and humans: effect of food and site of absorption","volume":"297","author":"Paulson S","year":"2001","journal-title":"J Pharmacol Exp Ther"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1270","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,1]],"date-time":"2023-11-01T03:14:39Z","timestamp":1698808479000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1270"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,5,29]]},"references-count":10,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2023,11]]}},"alternative-id":["10.1002\/cpdd.1270"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1270","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,5,29]]},"assertion":[{"value":"2023-02-13","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-04-25","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-05-29","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}