{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T06:51:05Z","timestamp":1791528665791,"version":"4.3.4"},"reference-count":30,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T00:00:00Z","timestamp":1791417600000},"content-version":"vor","delay-in-days":7,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"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":[[2026,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    We evaluated food\u2010associated differences in clindamycin hydrochloride capsule exposure by pooling publicly available regulatory bioequivalence (BE) summaries from the Center for Drug Evaluation of the National Medical Products Administration in China. Fourteen candidate regulatory identifiers were reviewed; one 0.15\u2010g BE\u2010exempt record without analyzable pharmacokinetic (PK) data was excluded, leaving 13 records (ten 150\u00a0mg and three 300\u00a0mg). CYHB1901758 and CYHB2140526 were treated as independent 300\u2010mg BE records under the authors\u2019 prespecified working assumption. For each record and endpoint, test and reference formulation fed\/fasted ratios were combined on the log scale, and regulatory records were pooled with equal weight. For the 150\u2010mg strength, pooled fed\/fasted geometric mean ratios (GMRs) [95% descriptive interval] were 1.31 [1.24, 1.38] for AUC\n                    <jats:sub>0\u2013t<\/jats:sub>\n                    , 1.30 [1.23, 1.38] for AUC\n                    <jats:sub>0\u2013inf<\/jats:sub>\n                    , and 0.85 [0.80, 0.90] for C\n                    <jats:sub>max<\/jats:sub>\n                    . For the 300\u2010mg strength, the corresponding GMRs were 1.17 [0.92, 1.50], 1.19 [0.93, 1.52], and 0.93 [0.88, 0.97]. Thus, the available aggregate summaries showed higher total exposure and lower peak concentration under fed conditions, particularly for the 150\u2010mg strength. These findings describe a food\u2010associated PK pattern but do not constitute a formal regulatory food\u2010effect assessment or support a change in meal\u2010timing recommendations.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70105","type":"journal-article","created":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T06:33:55Z","timestamp":1791527635000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Fed\u2013Fasted Differences in Clindamycin Hydrochloride Capsule Pharmacokinetics: A Pooled Analysis of Publicly Available China CDE Regulatory Summaries"],"prefix":"10.1002","volume":"15","author":[{"given":"Rui","family":"Li","sequence":"first","affiliation":[{"name":"Department of Geriatrics China\u2010Japan Friendship Hospital  Chaoyang District Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deshuang","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Cardiology of Integrated traditional Chinese and Western Medicine China\u2010Japan Friendship Hospital  Chaoyang District Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lang","family":"Zhao","sequence":"additional","affiliation":[{"name":"Department of Emergency China\u2010Japan Friendship Hospital  Chaoyang District Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhengyi","family":"Cao","sequence":"additional","affiliation":[{"name":"Department of Hematology China\u2010Japan Friendship Hospital  Chaoyang District Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoyu","family":"Li","sequence":"additional","affiliation":[{"name":"Jinan Academician Workstation, Shandong Academy of Chinese Medicine, Lixia District  Jinan City Shandong Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mengxi","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Geriatrics China\u2010Japan Friendship Hospital  Chaoyang District Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,10,8]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/femsmc\/xtae013"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0308017"},{"issue":"6","key":"e_1_2_10_4_1","doi-asserted-by":"crossref","first-page":"345","DOI":"10.3390\/antibiotics9060345","article-title":"Clinical findings and antimicrobial susceptibility of anaerobic bacteria isolated in bloodstream infections","volume":"9","author":"Cobo F","year":"2020","journal-title":"Antibiotics"},{"issue":"7","key":"e_1_2_10_5_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"},{"issue":"9","key":"e_1_2_10_6_1","doi-asserted-by":"crossref","first-page":"538","DOI":"10.1055\/s-0031-1296241","article-title":"Comparative pharmacokinetics study of two different clindamycin capsule formulations: a randomized, two\u2010period, two\u2010sequence, two\u2010way crossover clinical trial in healthy volunteers","volume":"61","author":"Sanki 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