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Pharmacokinetics of levetiracetam XR 500mg tablets.

Author(s): Rouits E, Burton I, Guenole E, Troenaru MM, Stockis A, Sargentini-Maier ML

Affiliation(s): UCB Pharma S.A., Braine-l'Alleud, Belgium.

Publication date & source: 2009-04, Epilepsy Res., 84(2-3):224-31. Epub 2009 Mar 4.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

PURPOSE: To compare the relative bioavailability of levetiracetam extended-release tablets (XR) with immediate release tablets (IR) following single and multiple dosing; to assess the food effect and the dose-proportionality of XR from 1000 to 3000mg. METHODS: Two panels of 24 healthy subjects were enrolled. Study N01160 was a three-way crossover between IR fasted (single and repeated 500mg b.i.d.), XR fasted (single and repeated 1000mg o.d.) and XR with food (1000mg single dose). Study N01260 was a three-way crossover single dose-proportionality between XR 1000, 2000 and 3000mg. RESULTS: After single dose, levetiracetam XR and IR were bioequivalent with respect to AUC((0-t)), AUC(infinity) and C(max). The median t(max) was delayed from 0.9 to 4h. For the fed/fasted comparison, the confidence intervals around the C(max) and AUC ratios were within the 80-125% limits. At steady-state, the AUC(24h) were also bioequivalent. In the dose-proportionality trial, the AUC and C(max) increased linearly with the dose. Levetiracetam XR was well tolerated. CONCLUSIONS: Levetiracetam XR 1000mg o.d. is bioequivalent to levetiracetam IR 500mg b.i.d. There is no food effect, and the absorption of XR is dose-proportional from 1000 to 3000mg.

Page last updated: 2009-10-20

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