Assessment of ethnic differences in the pharmacokinetics of valsartan

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.