{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,2]],"date-time":"2026-04-02T09:42:53Z","timestamp":1775122973545,"version":"3.50.1"},"reference-count":26,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2025,7,15]],"date-time":"2025-07-15T00:00:00Z","timestamp":1752537600000},"content-version":"vor","delay-in-days":14,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2025,7,1]],"date-time":"2025-07-01T00:00:00Z","timestamp":1751328000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2025,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    The study aimed to demonstrate bioequivalence between generic and original polaprezinc granules by comparing pharmacokinetic (PK) profiles in healthy Chinese subjects under fasting and fed conditions. This PK investigation was conducted with two independent, randomized, open\u2010label, single\u2010dose, two\u2010period, cross\u2010over studies. Healthy Chinese fasting (\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u200924, 75\u2009mg) or fed (\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u200924, 300\u2009mg) subjects randomly received a single oral dose of the test or reference polaprezinc granules at each period. Blood samples were collected pre\u2010 and post\u2010dose for up to 12\u2009h. Blood zinc was determined using a validated ICP\u2010MS method. Primary PK endpoints were calculated using non\u2010compartmental methods, including peak concentration (\n                    <jats:italic>C<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    ) and the areas under the plasma concentration\u2010time curve (AUC\n                    <jats:sub>0\u2013t<\/jats:sub>\n                    , AUC\n                    <jats:sub>0\u2013\u221e<\/jats:sub>\n                    ). The geometric mean ratios (GMR) in primary PK endpoints between the test and reference products with 90% confidence intervals (CI) were calculated. Treatment\u2010emergent adverse events were assessed. In the fasting study,\n                    <jats:italic>C<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    , AUC\n                    <jats:sub>0\u2013t<\/jats:sub>\n                    and AUC\n                    <jats:sub>0\u2013\u221e<\/jats:sub>\n                    were 1.30\u2009\u00b1\u20090.30\u2009\u03bcg\/mL, 4.06\u2009\u00b1\u20091.13\u2009h\u00b7\u03bcg\/mL, and 4.43\u2009\u00b1\u20091.04\u2009h\u00b7\u03bcg\/mL following 75\u2009mg test product. In the fed study,\n                    <jats:italic>C<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    , AUC\n                    <jats:sub>0\u2013t<\/jats:sub>\n                    and AUC\n                    <jats:sub>0\u2013\u221e<\/jats:sub>\n                    were 0.91\u2009\u00b1\u20090.26\u2009\u03bcg\/mL, 3.26\u2009\u00b1\u20091.06\u2009h\u00b7\u03bcg\/mL, and 3.37\u2009\u00b1\u20091.07\u2009h\u00b7\u03bcg\/mL following 300\u2009mg test product. The reference product had comparable PK profiles. All 90% CIs of GMRs in\n                    <jats:italic>C<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    , AUC\n                    <jats:sub>0\u2013t<\/jats:sub>\n                    and AUC\n                    <jats:sub>0\u2013\u221e<\/jats:sub>\n                    between the two products were within 80.0%\u2013125.0%. Both study products were well\u2010tolerated with no serious adverse events. The generic and original polaprezinc granules were bioequivalent by pharmacokinetic comparisons in healthy Chinese subjects under fasting and fed conditions. The two polaprezinc formulations were well\u2010tolerated with no new safety signals.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Trial Registration:<\/jats:bold>\n                    CTR20210011\n                  <\/jats:p>","DOI":"10.1111\/cts.70278","type":"journal-article","created":{"date-parts":[[2025,7,15]],"date-time":"2025-07-15T14:23:58Z","timestamp":1752589438000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Pharmacokinetics and Safety of Polaprezinc Granules Oral Administration in Healthy Chinese Volunteers Under Fasting and Fed Conditions"],"prefix":"10.1111","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-3991-7306","authenticated-orcid":false,"given":"Min","family":"Xiao","sequence":"first","affiliation":[{"name":"Phase 1 Clinical Trial Research Unit The Sixth People's Hospital of Zhengzhou  Zhengzhou Henan People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-9937-0609","authenticated-orcid":false,"given":"Tian","family":"Dou","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Huai'an Chuzhou Hospital of Traditional Chinese Medicine  Huai'an Jiangsu People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-0902-4846","authenticated-orcid":false,"given":"Jia","family":"Ji","sequence":"additional","affiliation":[{"name":"Phase 1 Clinical Trial Research Unit The Sixth People's Hospital of Zhengzhou  Zhengzhou Henan People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0187-1732","authenticated-orcid":false,"given":"Caihua","family":"Zhu","sequence":"additional","affiliation":[{"name":"Phase 1 Clinical Trial Research Unit The Sixth People's Hospital of Zhengzhou  Zhengzhou Henan People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-1532-5920","authenticated-orcid":false,"given":"Yuan","family":"Yuan","sequence":"additional","affiliation":[{"name":"Phase 1 Clinical Trial Research Unit The Sixth People's Hospital of Zhengzhou  Zhengzhou Henan People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-7778-1268","authenticated-orcid":false,"given":"Hongmin","family":"Zhou","sequence":"additional","affiliation":[{"name":"Phase 1 Clinical Trial Research Unit The Sixth People's Hospital of Zhengzhou  Zhengzhou Henan People's Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-3641-3304","authenticated-orcid":false,"given":"Fangqiong","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine Haisco Pharmaceutical Group co., Ltd.  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