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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
DC Field | Value | Language |
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dc.contributor.author | Na, Joo Young | - |
dc.contributor.author | Yang, Eunsol | - |
dc.contributor.author | Kim, Jae-Hoon | - |
dc.contributor.author | Kwon, In Sun | - |
dc.contributor.author | Jin, Eun-Heui | - |
dc.contributor.author | Yu, Kyung-Sang | - |
dc.contributor.author | Kim, Jinsook | - |
dc.contributor.author | Lee, SeungHwan | - |
dc.contributor.author | Hong, Jang Hee | - |
dc.date.accessioned | 2022-06-22T00:27:21Z | - |
dc.date.available | 2022-06-22T00:27:21Z | - |
dc.date.created | 2022-05-19 | - |
dc.date.issued | 2022-05 | - |
dc.identifier.citation | Clinical Pharmacology in Drug Development, Vol.11 No.5, pp.615-622 | - |
dc.identifier.issn | 2160-763X | - |
dc.identifier.uri | https://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.language | 영어 | - |
dc.publisher | Sage Periodicals Press | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.identifier.doi | 10.1002/cpdd.1054 | - |
dc.citation.journaltitle | Clinical Pharmacology in Drug Development | - |
dc.identifier.wosid | 000740270800001 | - |
dc.identifier.scopusid | 2-s2.0-85122687797 | - |
dc.citation.endpage | 622 | - |
dc.citation.number | 5 | - |
dc.citation.startpage | 615 | - |
dc.citation.volume | 11 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Yu, Kyung-Sang | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
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