{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,4]],"date-time":"2025-02-04T08:10:04Z","timestamp":1738656604185,"version":"3.35.0"},"reference-count":20,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2024,11,25]],"date-time":"2024-11-25T00:00:00Z","timestamp":1732492800000},"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":[[2025,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The aim of this study was to investigate the pharmacokinetics, bioequivalence, and safety of generic trazodone hydrochloride sustained\u2010release tablet and its reference listed product in healthy Chinese subjects. An open, randomized, single\u2010dose, and 2\u2010period crossover study was involved under fasting and fed conditions, with a 7\u2010day washout period. A single oral dose of 150\u00a0mg of 2 trazodone hydrochloride sustained\u2010release tablets was administered to 84 healthy volunteers, with 36 in the fasting group and 48 consuming a high\u2010fat diet, respectively. The plasma concentrations of trazodone were analyzed using a liquid chromatography\u2010tandem mass spectrometry method, and pharmacokinetic parameters were obtained from concentration\u2010time profiles. The geometric mean ratio with 90% confidence intervals of the maximum trazodone concentration, area under the plasma concentration\u2010time curve (AUC) from time 0 to the last measurable concentration, and AUC from time 0 to infinity were within the bioequivalence acceptance criteria (80%\u2010125%) under fasting and fed conditions, which indicated that the test and reference formulations were bioequivalent. Compared with the fasting study, the concomitant administration of trazodone with a high\u2010fat diet had a negligible influence on the drug pharmacokinetic behavior. Adverse events were recorded, and no serious adverse events were observed during either fasting or fed conditions. Trazodone has proven to have an acceptable safety profile in the Chinese population, with bioequivalence successfully established under both fasting and fed conditions.<\/jats:p>","DOI":"10.1002\/cpdd.1490","type":"journal-article","created":{"date-parts":[[2024,11,26]],"date-time":"2024-11-26T07:59:22Z","timestamp":1732607962000},"page":"177-183","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetics and Bioequivalence Evaluation of Trazodone Hydrochloride Sustained\u2010Release Tablets in Healthy Chinese Volunteers"],"prefix":"10.1002","volume":"14","author":[{"given":"Jingyan","family":"Wang","sequence":"first","affiliation":[{"name":"College of Health Industry Sichuan Tourism University  Chengdu Sichuan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuan","family":"Xu","sequence":"additional","affiliation":[{"name":"College of Health Industry Sichuan Tourism University  Chengdu Sichuan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhicheng","family":"Zhao","sequence":"additional","affiliation":[{"name":"Qingdao Fifth People's Hospital  Qingdao Shandong China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tian","family":"Meng","sequence":"additional","affiliation":[{"name":"College of Health Industry Sichuan Tourism University  Chengdu Sichuan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yang","family":"Zou","sequence":"additional","affiliation":[{"name":"College of Health Industry Sichuan Tourism University  Chengdu Sichuan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yi","family":"Lan","sequence":"additional","affiliation":[{"name":"Beijing Fengke Ruitai Pharmaceutical Technology Co. 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