{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,25]],"date-time":"2026-01-25T03:17:08Z","timestamp":1769311028534,"version":"3.49.0"},"reference-count":34,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2026,1,19]],"date-time":"2026-01-19T00:00:00Z","timestamp":1768780800000},"content-version":"vor","delay-in-days":18,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,1,1]],"date-time":"2026-01-01T00:00:00Z","timestamp":1767225600000},"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":[[2026,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    This first\u2010in\u2010human phase I trial evaluated RL001, a self\u2010emulsifying soft\u2010capsule abiraterone developed to overcome the low bioavailability and food sensitivity associated with the 1000\u2010mg Zytiga tablet that is used with prednisone according to NCCN guidelines. Plasma concentrations were quantified by LC\u2010MS\/MS and modeled in Phoenix WinNonlin 8.1 and SAS; GeoMean confidence intervals compared pharmacokinetics. Against 1000\u2010mg abiraterone acetate tablet, the 200\u00a0mg RL001 achieved abiraterone C\n                    <jats:sub>max<\/jats:sub>\n                    GMR &gt;125% and AUC\n                    <jats:sub>0\u2010t<\/jats:sub>\n                    , AUC\n                    <jats:sub>0\u2010\u221e<\/jats:sub>\n                    80\u2013125%, indicating higher bioavailability and enabling a lower therapeutic dose. The GMR of prednisone and its metabolite remained within 80%\u2013125%, confirming no interaction. Fed\/fasted exposure ratios stayed around 80% for AUC and &lt;80% for C\n                    <jats:sub>max<\/jats:sub>\n                    , eliminating food spikes. Hyperbilirubinemia and hypertriglyceridemia were significantly less frequent. The abiraterone self\u2010emulsifying soft capsule represents a safer and more convenient therapeutic option in the management of prostate cancer.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70011","type":"journal-article","created":{"date-parts":[[2026,1,19]],"date-time":"2026-01-19T09:00:27Z","timestamp":1768813227000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Evaluation of a New Formulation That Improves the Bioavailability and Food Effect of Abiraterone: An Open\u2010Label, Crossover, Randomized, Controlled, Phase I Clinical Trial"],"prefix":"10.1002","volume":"15","author":[{"given":"Mulin","family":"Yi","sequence":"first","affiliation":[{"name":"Center for Medical Genetics and Hunan Key Laboratory of Medical Genetics School of Life Sciences Central South University  Changsha Hunan P. R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shiqi","family":"Tu","sequence":"additional","affiliation":[{"name":"Xiangya School of Pharmaceutical Sciences Central South University  Changsha Hunan P. R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zeneng","family":"Cheng","sequence":"additional","affiliation":[{"name":"Xiangya School of Pharmaceutical Sciences Central South University  Changsha Hunan P. R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kun","family":"Xia","sequence":"additional","affiliation":[{"name":"Center for Medical Genetics and Hunan Key Laboratory of Medical Genetics School of Life Sciences Central South University  Changsha Hunan P. R. China"},{"name":"MOE Key Lab of Rare Pediatric Diseases Hengyang Medical School University of South China  Hengyang Hunan P. R. 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