{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T08:55:23Z","timestamp":1781513723894,"version":"3.54.1"},"reference-count":27,"publisher":"Springer Science and Business Media LLC","issue":"8","license":[{"start":{"date-parts":[[2026,2,14]],"date-time":"2026-02-14T00:00:00Z","timestamp":1771027200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,2,14]],"date-time":"2026-02-14T00:00:00Z","timestamp":1771027200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Atco Pharma for Pharmaceutical Industries, Egypt"},{"DOI":"10.13039\/501100002386","name":"Cairo University","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100002386","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Naunyn-Schmiedeberg's Arch Pharmacol"],"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Cariprazine, a third-generation antipsychotic, is indicated for schizophrenia and bipolar I disorder. Affordable formulations are essential for improving access and adherence, particularly in resource-limited settings. We aimed to assess the bioequivalence, safety, and tolerability of a newly developed generic hard capsule Vocarzine (1.5\u202fmg) compared to a branded reference product of cariprazine hard capsule (Reagila\u00ae) under fasting conditions in healthy adult participants. In a randomized, open-label, single-dose, two-period, two-sequence crossover design, 30 healthy male and female participants received a single oral dose of either the test or reference product, with 4-week washout period. Pharmacokinetics were evaluated using validated LC\u2013MS\/MS methods. Bioequivalence was concluded if the 90% confidence intervals (CIs) for the geometric mean ratios (GMRs) of peak plasma concentration (C\n                    <jats:sub>max<\/jats:sub>\n                    ) and area under the concentration\u2013time curve from time zero to 72 h (AUC\n                    <jats:sub>0-72h<\/jats:sub>\n                    ) fell within 80\u2013125%. Twenty-nine participants completed the study. The GMR (90% CI) for C\n                    <jats:sub>max<\/jats:sub>\n                    was 91.92% (85.07\u201399.33%) and for AUC\n                    <jats:sub>0-72h<\/jats:sub>\n                    was 92.85% (88.86\u201397.02%), both within the bioequivalence acceptance range (80\u2013125%). Both formulations were well tolerated; mild nausea was the most common adverse event, and no serious adverse events were reported. The two hard capsule formulations were bioequivalent, in terms of rate and extent of absorption, with a comparable safety profile, supporting the use of vocarzine as a safe, effective, and potentially cost-saving alternative.\n                    <jats:bold>Clinical trial number:<\/jats:bold>\n                    The ClinicalTrials.gov registration number is NCT07121868, retrospectively registered on August 13, 2025.\n                  <\/jats:p>","DOI":"10.1007\/s00210-026-05017-1","type":"journal-article","created":{"date-parts":[[2026,2,14]],"date-time":"2026-02-14T04:42:59Z","timestamp":1771044179000},"page":"11209-11220","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Bioequivalence evaluation of two cariprazine hard capsule formulations"],"prefix":"10.1007","volume":"399","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4425-4390","authenticated-orcid":false,"given":"Mamdouh R.","family":"Rezk","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kamal A.","family":"Badr","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmed Abd El Hamid","family":"Hosny","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6175-1690","authenticated-orcid":false,"given":"Aya M.","family":"Abdel Magid","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,2,14]]},"reference":[{"key":"5017_CR1","doi-asserted-by":"publisher","DOI":"10.1007\/s40268-025-00526-5","author":"AM AbdelMagid","year":"2025","unstructured":"AbdelMagid AM, Badr KA, Rezk MR (2025) Bioequivalence of two perampanel oral suspension formulations in healthy subjects: a randomized crossover study. 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The ClinicalTrials.gov registration number is\n                      NCT07121868\n                      , retrospectively registered on August 13, 2025. All procedures performed in the study involving human participants were in accordance with the ethical standards of the institutional committee, the Guidelines for Good Clinical Practice of the International Conference on Harmonisation, and the Helsinki Declaration and its later amendments (2013) or comparable ethical standards. Written informed consent was obtained from all participants prior to the initiation of the study procedures. The form was explained to all participants before signing it so that the nature, purpose, benefits and potential risks of the study were understood.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Ahmed Abd El Hamid Hosny is an employee of Atco Pharma for Pharmaceutical Industries, Egypt, which sponsored the study. The remaining authors declare that they have no competing interests regarding the content of this article.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}