Key result
Single-dose valsartan yields similar peak concentrations in healthy Japanese and Caucasian men.
Why the study?
Ethnic differences in the pharmacokinetics and pharmacodynamics of valsartan between Japanese and Caucasian subjects were assessed.
Are there ethnic differences in the pharmacokinetics and pharmacodynamics of a single 160 mg oral dose of valsartan between healthy male Japanese and Caucasian subjects?
Are there ethnic differences in the pharmacokinetics and pharmacodynamics of a single 160 mg oral dose of valsartan between healthy male Japanese and Caucasian subjects?
Answers are grounded in this paper and cite their sources.
The pharmacokinetics and pharmacodynamics of valsartan are similar between healthy Japanese and Caucasian men, suggesting no need for ethnic-specific dosing adjustments.
Purpose To assess the ethnic differences in the pharmacokinetics and pharmacodynamics of valsartan between Japanese and Caucasian subjects. Methods In this open label, parallel design study, a total of 15 healthy male Japanese and 15 healthy male Caucasian subjects received a single oral dose of 160 mg valsartan (Diovan®) capsule. Blood samples were collected at pre-determined time intervals to assess plasma valsartan, plasma renin activity, plasma aldosterone and plasma angiotensin II. Results Demographic data were similar between Japanese and Caucasian subjects. The time (Tmax) to reach peak plasma concentrations of valsartan was in the range of 1 - 6h. The mean (±SD) Cmax of valsartan was comparable (p-value= 0.217) between Japanese and Caucasian subjects (3.3 (±1.97) vs. 3.5 (±0.84) μg.h/mL). Similarly, the mean (±SD) plasma exposure indicated by AUC0-∞ (23 (±9.4) vs. 23.8 (±5.6) μg.h/mL) was also comparable (p-value =0.450). The mean (±SD) elimination half-life (t1/2) of valsartan was 7.7 (±1.5) h and 9.6 (±4.8) h in Japanese and Caucasian subjects, respectively. No significant difference (p-value>0.1) was found between two ethnic groups for plasma rennin activity, angiotensin II and aldosterone at 2, 4, and 8 hours post dose. Conclusions Pharmacokinetics of valsartan were similar between healthy male Caucasian and Japanese subjects. Clinical Pharmacology & Therapeutics (2005) 77, P79–P79; doi: 10.1016/j.clpt.2004.12.194
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Sunkara et al. (2005) studied Healthy (n=30). Valsartan in Japanese subjects vs. Valsartan in Caucasian subjects was evaluated on Cmax of valsartan (p=0.217). A single 160 mg oral dose of valsartan resulted in comparable peak plasma concentrations (Cmax) between healthy male Japanese and Caucasian subjects (3.3 vs. 3.5 μg.h/mL; P=0.217).
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