Levetiracetam intravenous infusion: a randomized, placebo-controlled safety and pharmacokinetic study
Steven Ramael1, Agnès Daoust, Christian Otoul
1SGS Life Sciences Services, Research Unit, Stuivenberg Hospital, Antwerp, Belgium. steven.ramael@sgs.com
Purpose:
The primary objective of this placebo-controlled study was to evaluate the safety and tolerability of levetiracetam (LEV) administered intravenously (IV) at higher doses and/or at a faster infusion rate than proposed. The secondary objective was to assess LEV pharmacokinetics.
Methods:
Single ascending doses of LEV administered by IV infusion (2,000, 3,000, 4,000 mg over 15 min; 1,500, 2,000, 2,500 mg over 5 min) were evaluated in 48 healthy subjects in a randomized, single-blind, placebo-controlled study.
Results:
All randomized subjects completed the study. Adverse events reported after IV administration of LEV (
Conclusions:
LEV administered by IV infusion at dosages and/or infusion rates higher than those proposed was well tolerated in healthy subjects, and the pharmacokinetic profile was consistent with that for LEV administered orally.
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