{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T21:28:33Z","timestamp":1793741313443,"version":"4.6.1"},"reference-count":36,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2024,3,12]],"date-time":"2024-03-12T00:00:00Z","timestamp":1710201600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The combined cilostazol and rosuvastatin therapy is frequently used for coronary artery disease treatment. This open\u2010label, 3\u00a0\u00d7\u00a03 crossover clinical trial evaluated the pharmacokinetics and safety of a fixed\u2010dose combination (FDC) of cilostazol\/rosuvastatin (200 + 20\u00a0mg) versus a concurrent administration of the separate components (SCs) under both fasted and fed conditions. Among 48 enrolled healthy adults, 38 completed the study. Participants were administered a single oral dose of cilostazol\/rosuvastatin (200 + 20\u00a0mg), either as an FDC or SCs in a fasted state, or FDC in a fed state, in each period of the trial. Blood samples were taken up to 48\u00a0hours after dosing, and plasma concentrations were analyzed using validated liquid chromatography\u2010tandem mass spectrometry. The geometric mean ratios of FDC to SCs for area under the plasma concentration\u2010time curve from time zero to the last quantifiable concentration (AUC<jats:sub>last<\/jats:sub>) and maximum plasma concentration (C<jats:sub>max<\/jats:sub>) were 0.94\/1.05 and 1.06\/1.15 for cilostazol and rosuvastatin, respectively (AUC<jats:sub>last<\/jats:sub>\/C<jats:sub>max<\/jats:sub>). Compared with that during fasting, fed\u2010state administration increased the AUC<jats:sub>last<\/jats:sub> and C<jats:sub>max<\/jats:sub> for cilostazol by approximately 72% and 160% and decreased these parameters for rosuvastatin by approximately 39% and 43%, respectively. To conclude, the FDC is bioequivalent to the SCs, with notable differences in pharmacokinetics when administered in a fed state. No significant safety differences were observed between the treatments.<\/jats:p>","DOI":"10.1002\/cpdd.1390","type":"journal-article","created":{"date-parts":[[2024,3,12]],"date-time":"2024-03-12T11:14:38Z","timestamp":1710242078000},"page":"842-851","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Pharmacokinetic and Safety Comparison of Fixed\u2010Dose Combination of Cilostazol\/Rosuvastatin (200 + 20 mg) Versus Concurrent Administration of the Separate Components in Healthy Adults"],"prefix":"10.1002","volume":"13","author":[{"given":"Jae Hoon","family":"Kim","sequence":"first","affiliation":[{"name":"Clinical Trials Center Chungnam National University Hospital  Daejeon Republic of Korea"},{"name":"Department of Medical Science Chungnam National University College of Medicine  Daejeon Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jang Hee","family":"Hong","sequence":"additional","affiliation":[{"name":"Clinical Trials Center Chungnam National University Hospital  Daejeon Republic of Korea"},{"name":"Department of Pharmacology Chungnam National University College of Medicine  Daejeon Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jin\u2010Gyu","family":"Jung","sequence":"additional","affiliation":[{"name":"Department of Family Medicine Chungnam National University Hospital  Daejeon Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Won Tae","family":"Jung","sequence":"additional","affiliation":[{"name":"Korea United Pharmaceutical Corporation  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyu\u2010Yeol","family":"Nam","sequence":"additional","affiliation":[{"name":"Korea United Pharmaceutical Corporation  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jae 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