Bioequivalence of two formulations of levetiracetam.
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.
Franco Spínola
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AC
Medical Department, Grupo Tecnimede, Sintra, Portugal. dmed.ct.tecnimede@mail.telepac.pt
Almeida
S
S
Filipe
A
A
Neves
R I
RI
Tanguay
M
M
Yritia
M
M
D000284:Administration, Oral; D000328:Adult; D000704:Analysis of Variance; D000927:Anticonvulsants / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D005215:Fasting; D005260:Female; D006207:Half-Life; D006801:Humans; D000077287:Levetiracetam; D008297:Male; D008875:Middle Aged; D010889:Piracetam / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics; D013810:Therapeutic Equivalency
D000927:Anticonvulsants; D000077287:Levetiracetam; D010889:Piracetam