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Nabumetone and 6-mna pharmacokinetics, assessment of intrasubject variability and gender effect

American Journal of Therapeutics, ISSN: 1536-3686, Vol: 23, Issue: 6, Page: e1498-e1503
2016
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In this open-label, laboratory-blinded, 2-way single dose study in 24 volunteers of both sexes we found that (1) nabumetone reaches mean Cmax 6 SD of 0.56 6 0.20 mgL21 at mean tmax of 8.63 6 7.05 hours, and mean area under the curve (AUC)last of 18.07 6 7.19 hmgL21; (2) there are no statistically significant differences between both sexes in pharmacokinetics of nabumetone; (3) 6-methoxy-2-naphthylacetic acid (6-MNA) reaches higher AUClast in men compared with women (mean 6 SD, 721.23 6 185.53 hmgL21 and 545.27 6 97.69 hmgL21, respectively; P 5 0.013); (4) there is lower 6-MNA clearance in men (0.65 6 0.22 Lh21) in comparison with women (0.88 6 0.18 Lh21, P 5 0.019), (5) intersubject variability of nabumetone and 6-MNA is between 35%-45% and 10%-30% for all assessed pharmacokinetics parameters (AUClast, Cmax, partial AUC values); (6) intrasubject variability (ISCV) for AUClast is low, 15.59% and 6.40% for nabumetone and 6-MNA, respectively, (7) ISCV for Cmax is 13.66% and 5.42% for nabumetone and 6-MNA, respectively. Nabumetone thus belongs to compounds with low to moderate ISCV and therefore this product is expected to produce consistent effects in clinical practice.

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