{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T11:17:27Z","timestamp":1788347847396,"version":"build-2803163510"},"reference-count":24,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2024,2,23]],"date-time":"2024-02-23T00:00:00Z","timestamp":1708646400000},"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":[[2024,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>This study evaluated the bioequivalence of the newly developed dapoxetine hydrochloride tablet relative to the marketed reference product by comparing their pharmacokinetic profiles under fasted and fed conditions. A total of 60 healthy Chinese male subjects participated in a single\u2010center, 2\u2010period, 2\u2010sequence, randomized, open\u2010label, self\u2010crossover study with a washout period of 14 days, 30 in the fasted group and 30 in the fed group. Following a single 30\u2010mg oral dose of the test or reference dapoxetine formulation, blood samples were collected before dosing to 72 hours after dosing. Liquid chromatography\u2010tandem mass spectrometry was performed to measure plasma concentration of dapoxetine and determine pharmacokinetic parameters through noncompartmental analysis. The vital signs and adverse events were also monitored during the study. The 90% confidence intervals of the geometric mean ratios for maximum plasma concentration, area under the plasma concentration\u2010time curve from time 0 to the last concentration time, and area under the plasma concentration\u2010time curve from time 0 extrapolated to infinity of the 2 dapoxetine formulations completely fell within the regulatory criteria for bioequivalence of 80%\u2010125%. In addition, both dapoxetine hydrochloride formulations were generally well tolerated. The generic dapoxetine hydrochloride tablet was bioequivalent to the marketed reference product in healthy Chinese men with no discernible safety differences.<\/jats:p>","DOI":"10.1002\/cpdd.1393","type":"journal-article","created":{"date-parts":[[2024,2,24]],"date-time":"2024-02-24T02:48:15Z","timestamp":1708742895000},"page":"861-869","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Bioequivalence Assessment of Two Dapoxetine Hydrochloride Formulations in Healthy Chinese Males Under Fasted and Fed Conditions"],"prefix":"10.1002","volume":"13","author":[{"given":"Yumin","family":"Li","sequence":"first","affiliation":[{"name":"Key Laboratory of Marine Drugs Chinese Ministry of Education School of Medicine and Pharmacy Ocean University of China  Qingdao China"},{"name":"School of Chemical Engineering Xuzhou Vocational College of Industrial Technology  Xuzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhen","family":"Zhang","sequence":"additional","affiliation":[{"name":"Shandong Hubble Kisen Biological Technology CO., Ltd.  Jinan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jizhen","family":"Xie","sequence":"additional","affiliation":[{"name":"Shandong Center for Food and Drug Evaluation and Inspection  Jinan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xianghua","family":"Lian","sequence":"additional","affiliation":[{"name":"Shandong Hubble Kisen Biological Technology CO., Ltd.  Jinan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guangtao","family":"Zhang","sequence":"additional","affiliation":[{"name":"Shandong Hubble Kisen Biological Technology CO., Ltd.  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