ASSESSMENT OF ETHNIC DIFFERENCES IN THE PHARMACOKINETICS OF VALSARTAN
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Sunkara, Gangadhar, Yeh, Ching-Ming, Ligueros-Saylan, Monica, Kawashita, Hiroto, Koseki, Nozomu and Fukui, Yoshihiro (2010) ASSESSMENT OF ETHNIC DIFFERENCES IN THE PHARMACOKINETICS OF VALSARTAN. Journal of Bioequivalence and Bioavailability, 2 (6). pp. 120-124. ISSN 0975-0851
Abstract
In this study, the potential for ethnic differences in the pharmacokinetics and pharmacodynamics of valsartan between Japanese and Caucasian subjects was assessed. This was an open-label, parallel design study conducted in age and body weight matched healthy male Japanese (n=15) and Caucasian (n=15) subjects. All subjects received a single oral dose of 160 mg valsartan capsule, and the plasma levels of valsartan, aldosterone, and angiotensin II along with plasma renin activity (PRA) were determined at pre-determined time intervals post-dosing. The time to reach peak plasma concentrations of valsartan (Tmax) was in the range of 1–6 h in both groups. The mean Cmax of valsartan was 3.3 and 3.5 µg/mL in Japanese and Caucasian subjects, respectively, and the corresponding mean plasma exposure (AUC0-∞) values were 23.0 and 23.8 µg.h/mL. The mean elimination half-life (t1/2) of valsartan was 7.7 and 9.6 h in Japanese and Caucasian subjects, respectively. No significant difference (p>0.1) was found between two ethnic groups for PRA, angiotensin II and aldosterone at 2, 4 and 8 h post dose. In conclusion, pharmacokinetics and pharmacodynamics of valsartan were not found to be ethnic sensitive between healthy male Caucasian and Japanese subjects following single oral dose administration of valsartan.
| Item Type: | Article |
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| Additional Information: | This work was approved for external presentation by Pharma Dev legal and International Project team in Y2005. This was presented at the ASCPT-2005 annual meeting |
| Keywords: | ethnic; pharmacodynamics; pharmacokinetics; valsartan |
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| Date Deposited: | 13 Oct 2015 13:16 |
| Last Modified: | 13 Oct 2015 13:16 |
| URI: | https://oak.novartis.com/id/eprint/2267 |