Levetiracetam intravenous infusion: a randomized, placebo-controlled safety and pharmacokinetic study |
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Authors: | Ramael Steven Daoust Agnès Otoul Christian Toublanc Nathalie Troenaru Mona Lu Zhihong Sarah Stockis Armel |
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Affiliation: | SGS Life Sciences Services, Research Unit, Stuivenberg Hospital, Antwerp, Belgium. steven.ramael@sgs.com |
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Abstract: | 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 (
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Keywords: | Epilepsy Intravenous infusion Levetiracetam Pharmacokinetics Safety |
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