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We conducted a single\u2010center, single\u2010dose, 2\u2010preparation, 2\u2010period, 2\u2010sequence, randomized, open\u2010label, 2\u00a0\u00d7\u00a02 crossover study to evaluate the pharmacokinetics (PKs) and safety of the test and reference clindamycin hydrochloride capsules in healthy Chinese subjects under both fasted and fed conditions. Forty\u2010eight subjects were enrolled in the study totally, with 24 subjects in each group. All subjects were asked to take a test or reference preparation, under either fasted or fed condition, and their blood samples were collected and assayed by a validated high\u2010performance liquid chromatography\u2010tandem mass spectrometry method. PK parameters including maximum plasma concentration, area under the plasma concentration\u2010time curve from time 0 to the last concentration, and area under the plasma concentration\u2010time curve from time 0 to infinity were estimated with noncompartmental model and analyzed. Results showed that the PK profiles of the 2 preparations were consistent and met the bioequivalence criteria. Food was identified as a factor that had an impact on clindamycin absorption. The safety of clindamycin hydrochloride capsules was satisfactory. This study proved that the 2 clindamycin hydrochloride capsules were bioequivalent in healthy Chinese subjects under both fasted and fed conditions.<\/jats:p>","DOI":"10.1002\/cpdd.1480","type":"journal-article","created":{"date-parts":[[2024,10,17]],"date-time":"2024-10-17T07:11:01Z","timestamp":1729149061000},"page":"127-132","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Bioequivalence Analysis of Clindamycin Hydrochloride Capsules in Healthy Chinese Subjects Under Fasted and Fed Conditions"],"prefix":"10.1002","volume":"14","author":[{"given":"Zhi","family":"Wang","sequence":"first","affiliation":[{"name":"Clinical Trial Research Organization Nancheng Hospital (Hepatobiliary Hospital)  Dongguan China"},{"name":"Clinical Research Center KangHua Hospital  Dongguan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haitang","family":"Wen","sequence":"additional","affiliation":[{"name":"Institute of Clinical Pharmacology School of Pharmaceutical Sciences Sun Yat\u2010sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xuebing","family":"Qian","sequence":"additional","affiliation":[{"name":"Clinical Trial Management &amp; Research Center College of Pharmacy Jinan University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Min","family":"Huang","sequence":"additional","affiliation":[{"name":"Institute of Clinical Pharmacology School of Pharmaceutical Sciences Sun Yat\u2010sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guohua","family":"Cheng","sequence":"additional","affiliation":[{"name":"Clinical Trial Management &amp; Research Center College of Pharmacy Jinan University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guoping","family":"Zhong","sequence":"additional","affiliation":[{"name":"Clinical Research Center KangHua Hospital  Dongguan China"},{"name":"Institute of Clinical Pharmacology School of Pharmaceutical Sciences Sun Yat\u2010sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,10,17]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciq146"},{"key":"e_1_2_9_3_1","volume-title":"StatPearls","author":"Murphy PB","year":"2024"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bcp.2016.12.001"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2012.04292.x"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/7.suppl_A.3"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2885.1998.00111.x"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.40.5.1134"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.03086-15"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.02014-16"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.31.7.878"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijantimicag.2023.106885"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmi.2021.04.017"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijantimicag.2006.04.013"},{"issue":"7","key":"e_1_2_9_15_1","first-page":"358","article-title":"Pharmacokinetics and bioequivalence study of clindamycin hydrochloride formulations after single\u2010dose administration in healthy Chinese male volunteers","volume":"58","author":"Li J","year":"2008","journal-title":"Arzneimittelforschung"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0031-1296241"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.5414\/CP201478"},{"issue":"8","key":"e_1_2_9_18_1","first-page":"386","article-title":"Bioavailability and selected pharmacokinetic parameters of clindamycin hydrochloride after administration of a new 600\u00a0mg tablet formulation","volume":"37","author":"Mazur D","year":"1999","journal-title":"Int J Clin Pharmacol Ther"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1480","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,3]],"date-time":"2025-02-03T10:26:10Z","timestamp":1738578370000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1480"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,10,17]]},"references-count":17,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2025,2]]}},"alternative-id":["10.1002\/cpdd.1480"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1480","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,10,17]]},"assertion":[{"value":"2024-08-21","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-09-26","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-10-17","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}