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The objective of this trial was to assess the bioequivalence of a 30\u2010mg nifedipine controlled\u2010release tablet and a reference drug in a cohort of healthy Chinese individuals. Two independent open\u2010label, randomized, single\u2010dose, crossover studies were conducted, 1 under fasting conditions (N = 44, with 1 participant dropping out midway) and the other under fed conditions (N = 44, with 4 participants dropping out midway). Plasma concentrations of nifedipine were determined using liquid chromatography\u2010mass spectrometry, and pharmacokinetic (PK) parameters were calculated using noncompartmental analysis with Phoenix WinNonlin 8.0 software. In both fasting and fed studies, reasonable bioequivalence was observed for the PK parameters of both the test product and the reference drug. A good safety profile was demonstrated for both the test product and reference drug, with no serious adverse events reported, and both were similarly well tolerated. An important observation with food coadministration was that systemic exposure to nifedipine (based on area under the curve, AUC<jats:sub>0\u2010\u221e<\/jats:sub>) was reduced by approximately 12%. The bioequivalence of the test product and reference drug under fasting\/fed conditions in healthy subjects in China was demonstrated by the study results.<\/jats:p>","DOI":"10.1002\/cpdd.1396","type":"journal-article","created":{"date-parts":[[2024,3,13]],"date-time":"2024-03-13T16:09:19Z","timestamp":1710346159000},"page":"499-505","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Comparative Bioequivalence and Food Effect of Two Formulations of 30\u2010mg Nifedipine Controlled\u2010Release Tablets in Healthy Chinese Adults"],"prefix":"10.1002","volume":"13","author":[{"given":"Huizi","family":"Zhang","sequence":"first","affiliation":[{"name":"School of Pharmacy Shanxi Medical University  Taiyuan, SX China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siyang","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Second Hospital of Shanxi Medical University  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