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Levetiracetam: Relative Bioavailability and Bioequivalence of a 10% Oral Solution (750 mg) and 750-mg Tablets

From UCB S.A. Pharma Sector, Chemin du Foriest, Braine l'Alleud, Belgium (Mr. Coupez, Mr. Straetemans, Dr. Stockis) and UCB Pharma Inc., Smyrna, Georgia (Dr. Sehgal, Dr. Lu).

Levetiracetam, an antiepileptic drug, is used worldwide as an adjunctive treatment for partial-onset seizures. The availability of a new oral solution formulation would provide an additional treatment option for patients who have difficulty swallowing tablets. A phase I single-center, randomized, open-label, two-way crossover, single-dose study was conducted to confirm that a 10% oral solution of levetiracetam was bioequivalent to the 750-mg oral tablet and to characterize its pharmacokinetics. Each of 24 healthy subjects received a single oral 750-mg dose of the randomized levetiracetam formulation (7.5 mL of 10% solution or 750-mg tablet) on day 1 and a single oral dose of the alternate formulation on day 8. Serial blood samples were collected from 0 to 36 hours after each dose administration for determination of plasma levetiracetam concentrations. Pharmacokinetic parameters were calculated, and bioequivalence of the two formulations was evaluated. The mean levetiracetam plasma concentration-time curves and pharmacokinetic parameters essentially were identical for the oral 10% solution and tablet and consistent with previously reported levetiracetam pharmacokinetics. The 90% confidence limits of the geometric mean ratio of the two formulations for area under the plasma concentration-time curve from time 0 to infinity, area under the plasma concentration-time curve from time 0 to last measurable time point, and maximum plasma concentration were within the 80% to 125% range, demonstrating bioequivalence of the two formulations. Both levetiracetam formulations were well tolerated. The levetiracetam 10% oral solution is a bioequivalent, well-tolerated alternative to the tablet formulation in patients who have difficulty swallowing.

Key Words: Levetiracetam • epilepsy • antiepileptic drugs • bioavailability • pharmacokinetics • bioequivalence

Address for reprints: Zhihong (Sarah) Lu, MD, PhD, UCB Pharma, Inc., 1950 Lake Park Drive, Smyrna, GA 30080.

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