{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,24]],"date-time":"2026-03-24T14:33:42Z","timestamp":1774362822631,"version":"3.50.1"},"reference-count":26,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2026,3,22]],"date-time":"2026-03-22T00:00:00Z","timestamp":1774137600000},"content-version":"vor","delay-in-days":21,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,3,1]],"date-time":"2026-03-01T00:00:00Z","timestamp":1772323200000},"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":[[2026,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Deutetrabenazine, a deuterated vesicular monoamine transporter 2 (VMAT2) inhibitor, is approved for the treatment of Huntington's disease (HD)\u2010related chorea and tardive dyskinesia (TD). However, pharmacokinetics (PK) and bioequivalence (BE) evidence in the Chinese population has been lacking. This single\u2010center, randomized, open\u2010label, single\u2010dose, two\u2010formulation, four\u2010period, fully replicated crossover study evaluated the PK, BE, and safety of test and reference deutetrabenazine 12\u00a0mg tablets under fasting and fed conditions in healthy Chinese volunteers. A total of 90 subjects were enrolled (40 fasting; 50 fed), and 88 completed the study. Plasma concentrations of deutetrabenazine and its active metabolites d6\u2010\u03b1\u2010dihydrotetrabenazine (d6\u2010\u03b1\u2010HTBZ) and d6\u2010\u03b2\u2010dihydrotetrabenazine (d6\u2010\u03b2\u2010HTBZ) were quantified using a validated liquid chromatography\u2010tandem mass spectrometry method. BE was assessed using average bioequivalence (ABE) or reference\u2010scaled average bioequivalence (RSABE) according to within\u2010subject variability. Under fasting conditions, RSABE was applied for maximum plasma concentration (C\n                    <jats:sub>max<\/jats:sub>\n                    ) and met equivalence criteria (point estimate within 80%\u2013125%, upper confidence interval bound \u2264 0); under fed conditions, as well as for all remaining PK parameters, ABE criteria were met with the 90% confidence interval within the 80%\u2013125% range. Both formulations were well tolerated, with only mild and transient adverse events and no serious safety findings. These results demonstrate that the test and reference deutetrabenazine tablets are bioequivalent in healthy Chinese adults under both nutritional states.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70054","type":"journal-article","created":{"date-parts":[[2026,3,23]],"date-time":"2026-03-23T04:10:13Z","timestamp":1774239013000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetics and Bioequivalence of 2 Deutetrabenazine Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions"],"prefix":"10.1002","volume":"15","author":[{"given":"Dayong","family":"Xu","sequence":"first","affiliation":[{"name":"Graduate School Hunan University of Chinese Medicine  Changsha Hunan P. R. China"},{"name":"Department of Pharmacy The Third Hospital of Changsha  Changsha Hunan P. R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pengkai","family":"Wang","sequence":"additional","affiliation":[{"name":"School of Biomedical Sciences Hunan University  Changsha Hunan P. R. China"},{"name":"Department of Pharmacy The Third Hospital of Changsha  Changsha Hunan P. R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuan","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Pharmacy The Third Hospital of Changsha  Changsha Hunan P. R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ping","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Pharmacy The Third Hospital of Changsha  Changsha Hunan P. R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liying","family":"Wei","sequence":"additional","affiliation":[{"name":"Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd  Jiangsu, Nanjing P. R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaolian","family":"Xiong","sequence":"additional","affiliation":[{"name":"Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd  Jiangsu, Nanjing P. R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xin","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Pharmacy The Third Hospital of Changsha  Changsha Hunan P. R. 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