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- W2056964549 abstract ": Purpose: Felbamate (FBM) pharmacokinetic parameters, safety and tolerability in the dose range of 1,200–6,000 mg/day were assessed in two open-label studies with similar designs. Methods: In study A, newly diagnosed subjects with epilepsy receiving FBM monotherapy at a starting dose of 1,200 mg/day (400 mg/three times daily, t.i.d.) and increased 1,200 mg/day, if tolerated, at 14-day intervals to 3,600 mg/day were investigated. In study B, epilepsy subjects with prior FBM monotherapy exposure received ascending FBM doses in five consecutive 14-day periods with a starting dose of 3,600 mg/day (1,200 mg t.i.d.) FBM. In each successive period, if FBM was well tolerated, the dose was increased by 600 mg/day to a maximum of 6,000 mg/day (2,000 mg t.i.d.). Results: The pharmacokinetic parameter estimates maximum observed concentration (Cmax), area under the concentration–time curve (AUCτ) Ctrough, and Cav showed a linear dependence to dose above the 1,200–6,000 mg/day FBM dose range (F-tests; p <0.0001) with apparent clearance (Cl/kg) and Tmax (time to Cmax) independent of dose. When AUCτ, Cmaxand Ctroughwere adjusted for dose, there were no significant differences between the dosing periods. Conclusions: The data establish that plasma concentrations of FBM are linear with respect to dose to 6,000 mg/day. In addition, FBM was safely administered at these doses for periods as long as 14 days to epileptic subjects with prior exposure to FBM. FBM-naive subjects appeared to report more adverse experiences (generally of mild to moderate severity) than did subjects with prior FBM exposure." @default.
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- W2056964549 date "1997-08-01" @default.
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- W2056964549 title "Tolerability and Pharmacokinetics of Monotherapy Felbamate Doses of 1,200-6,000 mg/day in Subjects with Epilepsy" @default.
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- W2056964549 doi "https://doi.org/10.1111/j.1528-1157.1997.tb01253.x" @default.
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