{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T01:13:40Z","timestamp":1790385220140,"version":"4.1.0"},"reference-count":14,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2024,9,10]],"date-time":"2024-09-10T00:00:00Z","timestamp":1725926400000},"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":[[2025,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Ticagrelor is a key antiplatelet agent used to prevent thrombotic events in patients with acute coronary syndrome. This open\u2010label, 2\u2010period, crossover Phase I study assessed the pharmacokinetics and bioequivalence of a generic ticagrelor 90\u2010mg formulation compared to the innovator product under fasting conditions. Twenty\u2010eight healthy White adults participated in the study. Each participant received a single dose of either the test or reference formulation, followed by a 7\u2010day washout period before switching to the alternate formulation. Plasma concentrations of ticagrelor were measured using a validated high\u2010performance liquid chromatography\u2010tandem mass spectrometry method. Statistical analysis of primary pharmacokinetic parameters, including maximum concentration and area under the plasma concentration\u2010time curve from time 0 to the last quantifiable concentration, showed bioequivalence with test\/reference ratios of 110.9% and 107.1%, respectively, and 90% confidence intervals within the 80%\u2010125% regulatory range. Treatment\u2010emergent adverse events, such as headache, dysphagia, and dizziness, were moderate and transient and resolved promptly, with no significant difference in incidence between the formulations. These results confirm that the generic ticagrelor formulation is bioequivalent to the innovator product, supporting its use as an interchangeable option in clinical practice.<\/jats:p>","DOI":"10.1002\/cpdd.1471","type":"journal-article","created":{"date-parts":[[2024,9,11]],"date-time":"2024-09-11T02:59:43Z","timestamp":1726023583000},"page":"59-64","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Pharmacokinetics and Bioequivalence of a Generic Ticagrelor 90\u2010mg Formulation Versus the Innovator Product in Healthy White Subjects Under Fasting Conditions"],"prefix":"10.1002","volume":"14","author":[{"given":"Simona","family":"Rizea\u2010Savu","sequence":"first","affiliation":[{"name":"3S\u2010Pharmacological Consultation &amp; Research GmbH  Harpstedt Germany"},{"name":"Titu Maiorescu University  Bucharest Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simona Nicoleta","family":"Duna","sequence":"additional","affiliation":[{"name":"3S\u2010Pharmacological Consultation &amp; Res. SRL  Bucharest Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adrian","family":"Ghita","sequence":"additional","affiliation":[{"name":"3S\u2010Pharmacological Consultation &amp; Res. 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