{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,20]],"date-time":"2026-06-20T07:19:27Z","timestamp":1781939967627,"version":"3.54.5"},"reference-count":20,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2024,1,12]],"date-time":"2024-01-12T00:00:00Z","timestamp":1705017600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2024,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Deutetrabenazine is approved for the treatment of tardive dyskinesia and chorea associated with Huntington's disease. This study compared the exposure between the once\u2010daily (test) and twice\u2010daily (reference) formulations of deutetrabenazine under fed conditions. Using a randomized crossover design, healthy adults (n = 262) received the 24\u00a0mg of the test formulation once daily and 12 mg of the reference formulation twice daily, each for 7\u00a0days. Plasma concentrations were collected on Days 4\u20106 before dose intake, and frequently for pharmacokinetic evaluation on Days 6 and 7 for determination of deutetrabenazine and active metabolites, deuterated \u03b1\u2010dihydrotetrabenazine (\u03b1\u2010HTBZ) and \u03b2\u2010dihydrotetrabenazine (\u03b2\u2010HTBZ). Geometric mean ratios (GMRs, test\/reference) were computed for all analytes, and bioequivalence was tested for area under the plasma concentration\u2010time curve over 24 hours at steady state (AUC<jats:sub>0\u201024\u00a0h,ss<\/jats:sub>) and for maximum plasma concentrations at steady state (C<jats:sub>max,ss<\/jats:sub>). The GMRs for AUC<jats:sub>0\u201024\u00a0h,ss<\/jats:sub> were 115% for deutetrabenazine and 95% for deuterated total (\u03b1+\u03b2)\u2010HTBZ; and the GMR for C<jats:sub>max,ss<\/jats:sub> for deutetrabenazine was 95%. Relative bioavailability was assessed for C<jats:sub>max,ss<\/jats:sub> of the active metabolites; the GMR was 78% for total (\u03b1+\u03b2)\u2010HTBZ. At steady state, deutetrabenazine administered as the once\u2010daily formulation was bioequivalent to the twice\u2010daily formulation for both AUC and C<jats:sub>max,<\/jats:sub> and the active metabolites were bioequivalent with regard to AUC<jats:sub>0\u201024\u00a0h,ss<\/jats:sub>.<\/jats:p>","DOI":"10.1002\/cpdd.1355","type":"journal-article","created":{"date-parts":[[2024,1,12]],"date-time":"2024-01-12T08:45:06Z","timestamp":1705049106000},"page":"224-232","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["A Bioequivalence Comparison Between the Once\u2010Daily Extended\u2010Release Tablet and the Twice\u2010Daily Tablet Formulations of Deutetrabenazine at Steady State"],"prefix":"10.1002","volume":"13","author":[{"given":"Eva\u2010Maria","family":"Sunzel","sequence":"first","affiliation":[{"name":"Innovative Medicines R&amp;D Global Clinical Development Teva Pharmaceuticals  West Chester PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Rabinovich\u2010Guilatt","sequence":"additional","affiliation":[{"name":"Innovative Medicines R&amp;D Global Clinical Development Teva Pharmaceuticals  Netanya Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Malini","family":"Iyengar","sequence":"additional","affiliation":[{"name":"Innovative Medicines R&amp;D Global Clinical Development Teva Pharmaceuticals  West Chester PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Debra","family":"Ruffo","sequence":"additional","affiliation":[{"name":"Innovative Medicines R&amp;D Global Clinical Development Teva Pharmaceuticals  West Chester PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nagnath G.","family":"Birajdar","sequence":"additional","affiliation":[{"name":"Watson Pharma Pvt. Ltd. Seawoods  Navi\u2010Mumbai Maharashtra India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pippa","family":"Loupe","sequence":"additional","affiliation":[{"name":"Innovative Medicines R&amp;D Global Clinical Development Teva Pharmaceuticals  West Chester PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Gutierrez","sequence":"additional","affiliation":[{"name":"Teva Clinics  Miramar FL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark Forrest","family":"Gordon","sequence":"additional","affiliation":[{"name":"Innovative Medicines R&amp;D Global Clinical Development Teva Pharmaceuticals  West Chester PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giulia","family":"Ghibellini","sequence":"additional","affiliation":[{"name":"Innovative Medicines R&amp;D Global Clinical Development Teva Pharmaceuticals  West Chester PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,1,12]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2215-0366(17)30236-5"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2016.8655"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000003960"},{"key":"e_1_2_7_5_1","first-page":"545","article-title":"Tetrabenazine in the treatment of Huntington's disease","volume":"3","author":"Paleacu D","year":"2007","journal-title":"Neuropsychiatr Dis Treat"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.12754"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.882"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1742-7843.2009.00485.x"},{"key":"e_1_2_7_9_1","first-page":"66","volume-title":"Clinical Pharmacokinetics Concepts and Applications","author":"Rowland M","year":"1995"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2016.04.082"},{"key":"e_1_2_7_11_1","unstructured":"FinkbeinerS LeoS Garc\u00eda HortonV ZhangS AyyagariR.Real\u2010World Adherence to Deutetrabenazine or Valbenazine Among Patients With Tardive Dyskinesia. World Congress on Parkinson's Disease and Related Disorders. Page 30. IAPRD 2023 abstract P_242.https:\/\/www.iaprd\u2010world\u2010congress.com\/inhalt\/uploads\/2023\/05\/IAPRD2023_Book\u2010of\u2010abstracts.pdf"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40120-021-00309-5"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.288.4.455"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.279.18.1458"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF03404494"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/17.suppl_A.16"},{"issue":"1","key":"e_1_2_7_17_1","first-page":"S75","article-title":"Compliance, electronic monitoring and antihypertensive drugs","volume":"16","author":"Mallion JM","year":"1998","journal-title":"J Hypertens Suppl"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(96)01073-2"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.4065\/mcp.2010.0575"},{"issue":"6","key":"e_1_2_7_20_1","first-page":"e22","article-title":"Effect of medication dosing frequency on adherence in chronic diseases","volume":"15","author":"Saini SD","year":"2009","journal-title":"Am J Manag Care"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.18553\/jmcp.2012.18.7.527"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1355","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,3,1]],"date-time":"2024-03-01T08:06:38Z","timestamp":1709280398000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1355"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,1,12]]},"references-count":20,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2024,3]]}},"alternative-id":["10.1002\/cpdd.1355"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1355","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,1,12]]},"assertion":[{"value":"2023-06-16","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-11-28","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-01-12","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}