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Comparative Pharmacokinetics Between a Fixed-Dose Combination of Pitavastatin/Valsartan 4/160 mg and the Corresponding Individual Components Through a Partial Replicated Crossover Design in Healthy Male Subjects

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dc.contributor.authorNa, Joo Young-
dc.contributor.authorYang, Eunsol-
dc.contributor.authorKim, Jae-Hoon-
dc.contributor.authorKwon, In Sun-
dc.contributor.authorJin, Eun-Heui-
dc.contributor.authorYu, Kyung-Sang-
dc.contributor.authorKim, Jinsook-
dc.contributor.authorLee, SeungHwan-
dc.contributor.authorHong, Jang Hee-
dc.date.accessioned2022-06-22T00:27:21Z-
dc.date.available2022-06-22T00:27:21Z-
dc.date.created2022-05-19-
dc.date.issued2022-05-
dc.identifier.citationClinical Pharmacology in Drug Development, Vol.11 No.5, pp.615-622-
dc.identifier.issn2160-763X-
dc.identifier.urihttps://hdl.handle.net/10371/182720-
dc.description.abstract© 2022, The American College of Clinical PharmacologyHypertension and hyperlipidemia are often comorbid, requiring combination therapies of antihypertensive drugs and antihyperlipidemia drugs. Taking 1 fixed-dose 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 mg and the corresponding individual components. Considering that valsartan is a highly variable drug for maximum plasma concentration (Cmax), an open-label, 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 mg 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 Cmax and area under the concentration-time curve from time 0 to the last measurable time point were 1.05 (90%CI, 0.96-1.15) and 0.10 (90%CI, 0.95-1.04) for pitavastatin and 1.15 (90%CI, 1.06-1.25) and 1.06 (0.99-1.14) for valsartan, respectively. The geometric mean ratios (90%CIs) for area under the concentration-time curve from time 0 to the last measurable time point and Cmax of both drugs were included in the bioequivalence criteria. In conclusion, the FDC of pitavastatin/valsartan 4/160 mg showed pharmacokinetic equivalence with the corresponding individual components.-
dc.language영어-
dc.publisherSage Periodicals Press-
dc.titleComparative Pharmacokinetics Between a Fixed-Dose Combination of Pitavastatin/Valsartan 4/160 mg and the Corresponding Individual Components Through a Partial Replicated Crossover Design in Healthy Male Subjects-
dc.typeArticle-
dc.identifier.doi10.1002/cpdd.1054-
dc.citation.journaltitleClinical Pharmacology in Drug Development-
dc.identifier.wosid000740270800001-
dc.identifier.scopusid2-s2.0-85122687797-
dc.citation.endpage622-
dc.citation.number5-
dc.citation.startpage615-
dc.citation.volume11-
dc.description.isOpenAccessN-
dc.contributor.affiliatedAuthorYu, Kyung-Sang-
dc.type.docTypeArticle-
dc.description.journalClass1-
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