{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,8,26]],"date-time":"2023-08-26T13:41:28Z","timestamp":1693057288643},"reference-count":27,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2022,1,8]],"date-time":"2022-01-08T00:00:00Z","timestamp":1641600000000},"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":[[2022,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Hypertension and hyperlipidemia are often comorbid, requiring combination therapies of antihypertensive drugs and antihyperlipidemia drugs. Taking 1 fixed\u2010dose combination (FDC) may increase patient compliance rather than taking each of the drugs separately. This study aimed to evaluate the pharmacokinetic bioequivalence between an FDC of pitavastatin\/valsartan 4\/160\u00a0mg and the corresponding individual components. Considering that valsartan is a highly variable drug for maximum plasma concentration (C<jats:sub>max<\/jats:sub>), an open\u2010label, randomized, partial replicated crossover study was conducted in 54 healthy subjects. The subjects received a single oral dose of the FDC of pitavastatin\/valsartan 4\/160\u00a0mg in 1 period or the corresponding individual components in the other 2 periods. The geometric mean ratios and their 90%CIs of the FDC to the corresponding individual components for C<jats:sub>max<\/jats:sub> and area under the concentration\u2010time curve from time 0 to the last measurable time point were 1.05 (90%CI, 0.96\u20101.15) and 0.10 (90%CI, 0.95\u20101.04) for pitavastatin and 1.15 (90%CI, 1.06\u20101.25) and 1.06 (0.99\u20101.14) for valsartan, respectively. The geometric mean ratios (90%CIs) for area under the concentration\u2010time curve from time 0 to the last measurable time point and C<jats:sub>max<\/jats:sub> of both drugs were included in the bioequivalence criteria. In conclusion, the FDC of pitavastatin\/valsartan 4\/160\u00a0mg showed pharmacokinetic equivalence with the corresponding individual components.<\/jats:p>","DOI":"10.1002\/cpdd.1054","type":"journal-article","created":{"date-parts":[[2022,1,8]],"date-time":"2022-01-08T13:01:09Z","timestamp":1641646869000},"page":"615-622","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Comparative Pharmacokinetics Between a Fixed\u2010Dose Combination of Pitavastatin\/Valsartan 4\/160\u00a0mg and the Corresponding Individual Components Through a Partial Replicated Crossover Design in Healthy Male Subjects"],"prefix":"10.1002","volume":"11","author":[{"given":"Joo Young","family":"Na","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Seoul National University College of Medicine and Hospital  Seoul Republic of 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