Bioequivalence of two formulations of levetiracetam

Int J Clin Pharmacol Ther. 2008 Nov;46(11):591-6. doi: 10.5414/cpp46591.

Abstract

This study was conducted in order to compare the bioavailability of two tablet formulations containing 1,000 mg levetiracetam, (S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, 102767-28-2 CAS registry number. 18 healthy subjects were enrolled in a single-center, randomized, single-dose, open-label, 2-way crossover study, with a minimum washout period of 7 days. Plasma samples were collected up to 36.0 hours post-dosing. Levetiracetam levels were determined by reverse liquid chromatography and detected by tandem mass spectrometry detection, LC-MS/MS method. Pharmacokinetic parameters used for bioequivalence assessment, area under the concentration-time curve from time 0 to time of last non-zero concentration (AUClast) and from time zero to infinitive (AUCinf) and maximum observed concentration (Cmax), were determined from the levetiracetam concentration data using non-compartmental analysis. The 90% confidence intervals obtained by analysis of variance were 88.98 - 108.75% for Cmax, 99.90 - 104.81% for AUClast and 100.11 - 105.23 %for AUCinf this is, within the predefined ranges. Bioequivalence between formulations was concluded both in terms of rate and extent of absorption.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Analysis of Variance
  • Anticonvulsants / blood
  • Anticonvulsants / pharmacokinetics*
  • Area Under Curve
  • Chemistry, Pharmaceutical
  • Cross-Over Studies
  • Fasting
  • Female
  • Half-Life
  • Humans
  • Levetiracetam
  • Male
  • Middle Aged
  • Piracetam / analogs & derivatives*
  • Piracetam / blood
  • Piracetam / pharmacokinetics
  • Therapeutic Equivalency

Substances

  • Anticonvulsants
  • Levetiracetam
  • Piracetam