{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,9,4]],"date-time":"2023-09-04T08:44:15Z","timestamp":1693817055309},"reference-count":20,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2020,5,26]],"date-time":"2020-05-26T00:00:00Z","timestamp":1590451200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"National Science and Technology Major Project","award":["2017ZX09101001-002-044"],"award-info":[{"award-number":["2017ZX09101001-002-044"]}]},{"name":"Beijing Health and Technical High-level Personal Plan","award":["2014-2-014"],"award-info":[{"award-number":["2014-2-014"]}]}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2020,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Clopidogrel is an antiplatelet drug with high intraindividual variability in systemic exposure and efficacy. It has been used for treating atherosclerosis and acute coronary syndrome and in preventing stent restenosis and thrombotic complications after stent implantation in clinical practice for nearly 20 years. In this study we aimed to evaluate the bioequivalence of 2 clopidogrel hydrogen sulfate formulations (75\u2010mg tablets) under fed (n = 66) and fasted (n = 66) conditions by using the reference\u2010scaled average bioequivalence method. An open\u2010label, randomized, 3\u2010sequence and 3\u2010period crossover (3\u00d73), semireplicated study was designed and conducted. Clopidogrel concentration of plasma samples was measured by high\u2010precision liquid chromatography and tandem mass spectrometry. The pharmacokinetic parameters were derived by a noncompartmental model. In the fed condition the geometric least\u2010squares mean ratios of peak concentration (C<jats:sub>max<\/jats:sub>) and area under the concentration\u2010time curve (AUC<jats:sub>0\u2010t<\/jats:sub>) were, respectively, 103.38% and 98.97%, and the corresponding 90%CIs were 95.68% to 111.70% and 94.67% to 103.47%. In the fasted condition the geometric least squares mean ratios of C<jats:sub>max<\/jats:sub> and AUC<jats:sub>0\u2010t<\/jats:sub> were, respectively, 106.53% and 105.77%, and the corresponding 90%CIs were 97.62% to 116.25% and 96.96% to 115.38%. According to the criteria for bioequivalence (80.00% to 125.00%), the test formulations of clopidogrel and Plavix were determined to be bioequivalent.<\/jats:p>","DOI":"10.1002\/cpdd.804","type":"journal-article","created":{"date-parts":[[2020,5,26]],"date-time":"2020-05-26T10:58:29Z","timestamp":1590490709000},"page":"813-820","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetics and Bioequivalence of Clopidogrel Hydrogen Sulfate Tablets in Fed and Fasted Conditions: An Open\u2010Label, Randomized, Semireplicated Crossover Study in Healthy Chinese Volunteers"],"prefix":"10.1002","volume":"9","author":[{"given":"Tong","family":"Pei","sequence":"first","affiliation":[{"name":"Department of Pharmacy Phase I Clinical Trial Center Xuanwu Hospital Capital Medical University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jing","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Cardiology Xuanwu Hospital Capital Medical University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chaoying","family":"Hu","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Phase I Clinical Trial Center Xuanwu Hospital Capital Medical University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaoping","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Phase I Clinical Trial Center Xuanwu Hospital Capital Medical University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shili","family":"Gong","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Phase I Clinical Trial Center Xuanwu Hospital Capital Medical University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiao","family":"Hu","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Phase I Clinical Trial Center Xuanwu Hospital Capital Medical University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lin","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Phase I Clinical Trial Center Xuanwu Hospital Capital Medical University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lan","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Phase I Clinical Trial Center Xuanwu Hospital Capital Medical University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,5,26]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1177\/1358836X9800300312"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.dmpk.2019.05.005"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1161\/STR.0000000000000158"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1160\/TH08-01-0049"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcpt.12916"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.117.078162"},{"issue":"7","key":"e_1_2_10_8_1","doi-asserted-by":"crossref","first-page":"463","DOI":"10.1097\/FPC.0b013e3283385420","article-title":"Clopidogrel pathway","volume":"20","author":"Sangkuhl K","year":"2010","journal-title":"Pharmacogenet Genomics."},{"issue":"1","key":"e_1_2_10_9_1","first-page":"1","article-title":"In situ 3D topographic and shape analysis by synchrotron radiation X\u2010ray microtomography for crystal form identification in polymorphic mixtures","volume":"6","author":"Yin X","year":"2016","journal-title":"Sci Rep\u2010UK"},{"issue":"5","key":"e_1_2_10_10_1","first-page":"65","article-title":"The study of clopidogrel hydrogen sulfate crystal characteristics","volume":"27","author":"Chen D F","year":"2015","journal-title":"Strait Pharm J"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.259"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.4238\/2015.December.14.1"},{"issue":"4","key":"e_1_2_10_13_1","first-page":"281","article-title":"Pharmacogenetic selection of volunteers increases stringency of bioequivalence studies; 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