{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,25]],"date-time":"2026-07-25T05:02:41Z","timestamp":1784955761217,"version":"3.55.0"},"reference-count":14,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T00:00:00Z","timestamp":1784505600000},"content-version":"vor","delay-in-days":19,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"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":[[2026,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Tamsulosin hydrochloride is a long\u2010acting, highly selective \u03b11A receptor antagonist, primarily used to treat benign prostatic hyperplasia. It effectively alleviates lower urinary tract symptoms, including dysuria, nocturia, and urgency caused by prostate enlargement. This study aimed to evaluate the pharmacokinetics and bioequivalence of two tamsulosin extended\u2010release capsules in Chinese volunteers under both fasting and fed conditions. A single\u2010center, randomized, open\u2010label, two\u2010formulation, single\u2010dose, two\u2010period, two\u2010way crossover design was used. A total of 64 healthy volunteers were enrolled, with 28 in the fasting group and 36 in the fed group. In the fasting group, each subject received a single dose of either the test or reference formulation in a randomized crossover design. In the fed group, volunteers consumed a high\u2010fat meal 1\u00a0h before dosing. Blood samples were collected for up to 72\u00a0h post\u2010dose, and plasma tamsulosin concentrations were measured using liquid chromatography\u2010tandem mass spectrometry. The geometric mean ratios and 90% confidence intervals for key exposure metrics for both formulations under fasting and fed conditions were within the 0.8000\u20101.2500 bioequivalence range. Both formulations demonstrated bioequivalence under both conditions, and no severe adverse events were observed.<\/jats:p>","DOI":"10.1002\/cpdd.70078","type":"journal-article","created":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T13:32:28Z","timestamp":1784554348000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetics and Bioequivalence of Tamsulosin Hydrochloride Extended\u2010Release Capsules in Healthy Chinese Volunteers: A Randomized, Open\u2010Label, Crossover Study Under Fasting and Fed Conditions"],"prefix":"10.1002","volume":"15","author":[{"given":"Lijie","family":"Du","sequence":"first","affiliation":[{"name":"School of Pharmacy Hubei University of Science and Technology  Xianning China"},{"name":"Phase I Clinical Research Center Xianning Central Hospital The First Affiliated Hospital of Hubei University of Science and Technology  Xianning China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaolu","family":"Wang","sequence":"additional","affiliation":[{"name":"Phase I Clinical Research Center Xianning Central Hospital The First Affiliated Hospital of Hubei University of Science and Technology  Xianning China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yi","family":"Zhang","sequence":"additional","affiliation":[{"name":"School of Pharmacy Hubei University of Science and Technology  Xianning China"},{"name":"Phase I Clinical Research Center Xianning Central Hospital The First Affiliated Hospital of Hubei University of Science and Technology  Xianning China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiamin","family":"Yang","sequence":"additional","affiliation":[{"name":"School of Pharmacy Hubei University of Science and Technology  Xianning China"},{"name":"Phase I Clinical Research Center Xianning Central Hospital The First Affiliated Hospital of Hubei University of Science and Technology  Xianning China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fangliang","family":"Gan","sequence":"additional","affiliation":[{"name":"Phase I Clinical Research Center Xianning Central Hospital The First Affiliated Hospital of Hubei University of Science and Technology  Xianning China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yaxun","family":"Pang","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery Xianning Central Hospital The First Affiliated Hospital of Hubei University of Science and Technology  Xianning China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,20]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.2165\/00002512-200219020-00004"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.1589"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.14740\/jocmr5255"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics17101264"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.12793\/tcp.2015.23.1.21"},{"key":"e_1_2_11_7_1","volume-title":"Announcement on the Release of Reference Listed Drug (RLD) catalogue for generic drugs","author":"National Medical Products Administration of China","year":"2018"},{"key":"e_1_2_11_8_1","volume-title":"Announcement on the Release of Reference Listed Drug (RLD) catalogue for generic drugs","author":"National Medical Products Administration of China","year":"2018"},{"key":"e_1_2_11_9_1","unstructured":"Boehringer Ingelheim Pharmaceuticals Inc. (2010 April 6). Flomax\u00ae (tamsulosin hydrochloride) capsules 0.4\u00a0mg prescribing information. U.S. Food and Drug Administration. Accessed March 7 2026.http:\/\/www.accessdata.fda.gov\/scripts\/cder\/drugsatfda"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.12793\/tcp.2020.28.e17"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2010.03662.x"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-018-2501-x"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270011432168"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-199652060-00012"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejps.2019.04.003"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70078","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.70078","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70078","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,25]],"date-time":"2026-07-25T04:42:23Z","timestamp":1784954543000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.70078"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7]]},"references-count":14,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2026,7]]}},"alternative-id":["10.1002\/cpdd.70078"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.70078","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7]]},"assertion":[{"value":"2026-03-29","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-10","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-07-20","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70078"}}