Bioequivalence study of the antiepileptic drug levetiracetam in concentrated solution for injection versus oral tablets in healthy Chinese subjects under fasting conditions: A randomized, open-label, three-way crossover study


International Journal of Clinical Pharmacology and Therapeutics
Junyu XuYimin Cui

Abstract

The objective of this study was to evaluate the bioequivalence between single-dose intravenous (IV) infusion injection (the infusion time was 15 minutes and 45 minutes) and tablets of 1,000 mg levetiracetam in healthy Chinese male subjects. This was a randomized, open-label, three-way crossover bioequivalence study. All of the 24 healthy male subjects received a treatment of 45-minute IV infusion, 15-minute IV infusion, and oral tablets. After a single dose, the AUC, Vd, Cl, and T1/2 were all essentially consistent among the treatment; tmax of 15-minute IV, 45-minute IV, and oral tablets were 0.25 hours, 0.75 hours, and 0.5 hours, respectively. The Cmax of the 15-minute IV was higher than the value of the 45-minute IV and the oral tablets. The geometric mean of the 15-minute IV/oral and the 45-minute IV/oral ratios were 101.02% (90% CI, 98.95 - 103.12) and 98.22% (90% CI, 96.22 - 100.27), respectively, for AUC0-t. And those for Cmax were 169.09% (90% CI, 155.21 - 184.21) and 106.95 (90% CI, 98.20 - 116.48), respectively. There were no severe adverse events or other adverse events with clinical significance during the study. In these healthy subjects, the results showed that 45-minute IV and oral tablets were bioequivalent. The ...Continue Reading

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