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This study compared the bioequivalence and safety of the test nilotinib capsule and reference nilotinib capsule (Tasigna, Novartis) in healthy Chinese volunteers under fasting conditions for marketing authorization in China. The results of the study are reported for the first time. This was a single\u2010dose, randomized, open\u2010label, two\u2010period, and cross\u2010over study. Thirty healthy volunteers were randomly assigned to receive a single dose of a 200\u2010mg test or reference capsule under fasting conditions in each period with a 10\u2010day washout. Plasma samples were analyzed with liquid chromatography\u2010tandem mass spectrometry. Pharmacokinetic parameters were calculated with WinNonlin software. The geometric mean ratio and the corresponding 90% confidence intervals of C<jats:sub>max<\/jats:sub>, AUC<jats:sub>0\u2010t<\/jats:sub>, and AUC<jats:sub>0\u2010\u221e<\/jats:sub> for nilotinib between the two fixed\u2010dose combination formulations were within the bioequivalence acceptance range of 80%\u2013125%, therefore the generic and branded formulations were bioequivalent in healthy Chinese volunteers.<\/jats:p>","DOI":"10.1002\/cpdd.1148","type":"journal-article","created":{"date-parts":[[2022,7,28]],"date-time":"2022-07-28T12:18:33Z","timestamp":1659010713000},"page":"1233-1240","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetics, Bioequivalence, and Safety Studies of a Generic Selective Tyrosine Kinase Inhibitor Nilotinib Capsule Versus a Branded Product in Healthy Chinese Volunteers"],"prefix":"10.1002","volume":"11","author":[{"given":"Meng","family":"Wang","sequence":"first","affiliation":[{"name":"Department of Pharmacy The Second Affiliated Hospital of Soochow University  Suzhou City Jiangsu Province P.R. 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