{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T12:48:08Z","timestamp":1792673288603,"version":"4.5.0"},"reference-count":29,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T00:00:00Z","timestamp":1792627200000},"content-version":"vor","delay-in-days":21,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"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                    Enzalutamide is an oral second\u2010generation androgen receptor inhibitor used for advanced prostate cancer. This study evaluated the pharmacokinetics (PK), bioequivalence (BE), and safety of a newly developed generic enzalutamide soft capsule (test) compared with the reference product (XTANDI) in healthy Chinese adults under fasting and fed conditions. A single\u2010center, randomized, open\u2010label, two\u2010period, two\u2010sequence, crossover study was conducted in 72 male participants (36 fasting and 36 fed). Each participant received a single 40\u2010mg dose of test or reference formulation, separated by a 34\u2010day washout. Blood samples were collected up to 72\u00a0h post\u2010dose. PK parameters (C\n                    <jats:sub>max<\/jats:sub>\n                    and AUC\n                    <jats:sub>0\u201072\u00a0h<\/jats:sub>\n                    ) were calculated using non\u2010compartmental analysis. BE was assessed by 90% confidence intervals (CIs) of geometric mean ratios (GMRs). Safety was monitored throughout the study. In both fasting and fed conditions, the 90% CIs of GMRs for C\n                    <jats:sub>max<\/jats:sub>\n                    and AUC\n                    <jats:sub>0\u201072\u00a0h<\/jats:sub>\n                    were within the predefined 80%\u2013125% BE range. Both formulations exhibited a favorable single\u2010dose safety profile, with no serious adverse events reported. The test enzalutamide soft capsule is bioequivalent to the reference product in healthy Chinese volunteers, demonstrating similar PK profiles and safety. This study provides population\u2010specific PK evidence supporting the clinical use of the generic formulation in China.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70121","type":"journal-article","created":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T12:30:33Z","timestamp":1792672233000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Bioequivalence Study of Two Formulations of Enzalutamide Soft Capsules in Healthy Chinese Male Subjects"],"prefix":"10.1002","volume":"15","author":[{"given":"Jianxin","family":"Wang","sequence":"first","affiliation":[{"name":"School of pharmacy Ningxia Medical University  Yinchuan Ningxia Hui Autonomous Region China"},{"name":"Department of Pharmacy Gansu Provincial People's Hospital  Lanzhou Gansu Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kai","family":"Gu","sequence":"additional","affiliation":[{"name":"School of pharmacy Ningxia Medical University  Yinchuan Ningxia Hui Autonomous Region China"},{"name":"Department of Pharmacy Gansu Provincial People's Hospital  Lanzhou Gansu Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mingxuan","family":"Zhang","sequence":"additional","affiliation":[{"name":"Faculty of Health Sciences (FHS) University of Macau  Taipa Macau SAR China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miao","family":"Yu","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Gansu Provincial People's Hospital  Lanzhou Gansu Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pei","family":"Zhao","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Gansu Provincial People's Hospital  Lanzhou Gansu Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Yu","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Gansu Provincial People's Hospital  Lanzhou Gansu Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaohong","family":"Guo","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Gansu Provincial People's Hospital  Lanzhou Gansu Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yating","family":"Bai","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Gansu Provincial People's Hospital  Lanzhou Gansu Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Gansu Provincial People's Hospital  Lanzhou Gansu Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoli","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Gansu Provincial People's Hospital  Lanzhou Gansu Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaolai","family":"Yang","sequence":"additional","affiliation":[{"name":"School of pharmacy Ningxia Medical University  Yinchuan Ningxia Hui Autonomous Region China"},{"name":"Department of Pharmacy Gansu Provincial People's Hospital  Lanzhou Gansu Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,10,22]]},"reference":[{"issue":"3","key":"e_1_2_10_2_1","first-page":"229","article-title":"Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries","volume":"74","author":"Bray F","year":"2024","journal-title":"CA Cancer J Clin"},{"issue":"2","key":"e_1_2_10_3_1","doi-asserted-by":"crossref","first-page":"239","DOI":"10.1111\/bph.15300","article-title":"Mechanisms of enzalutamide resistance in castration\u2010resistant prostate cancer and therapeutic strategies to overcome 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