title: Comparative bioavailability study with two gemfibrozil tablet formulations in healthy volunteers.
abstract: OBJECTIVE
  To assess the bioequivalence of gemfibrozil (CAS 25812-30-0) 900 mg tablet formulation from EMS Farmaceutica as test formulation versus a 900 mg tablet formulation as reference in 36 healthy volunteers of both sexes.
  
  
  METHODS
  The study was conducted using an open, randomized, two-period crossover design with a 1-week washout interval. Plasma samples were obtained over a 24-h period. Plasma gemfibrozil concentrations were analyzed by liquid chromatography coupled to tandem mass spectrometry (LC-MS-MS) with negative ion electrospray ionization using multiple reaction monitoring (MRM). From the gemfibrozil plasma concentration vs time curves, the following pharmacokinetic parameters were obtained: AUClast, AUC(0-inf) and Cmax.
  
  
  RESULTS
  The limit of quantification was 0.05 microg/mL for plasma gemfibrozil analysis. The geometric mean and respective 90% confidence interval (CI) of Test/Reference percent ratios were 90.29 (81.39-100.17) for Cmax, 96.26 (90.33-102.59) for AUClast, 96.04 (90.21-102.23) for AUC(0-24 h) and 96.62 (90.82-102.78) for AUC(0-infinity).
  
  
  CONCLUSIONS
  Since the 90% CI for AUClast, AUC(0-inf) and Cmax, ratios were within the 80-125% interval proposed by the U.S. FDA, it was concluded that gemfibrozil 900 mg tablet (test formulation) was bioequivalent to the 900 mg tablet reference formulation for both rate and extent of absorption.
authors.affiliation: Department of Pharmacology, State University of Campinas, Campinas, SP, Brazil.
authors.forename: Ney Carter do C
authors.initials: NC
authors.lastname: Borges
authors.forename: Gustavo Duarte
authors.initials: GD
authors.lastname: Mendes
authors.forename: Rafael E
authors.initials: RE
authors.lastname: Barrientos-Astigarraga
authors.forename: Eduardo
authors.initials: E
authors.lastname: Zappi
authors.forename: Fabiana Duarte
authors.initials: FD
authors.lastname: Mendes
authors.forename: Gilberto
authors.initials: G
authors.lastname: De Nucci
mesh_terms: D000293:Adolescent; D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D005260:Female; D015248:Gemfibrozil / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006801:Humans; D000960:Hypolipidemic Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D008297:Male; D013058:Mass Spectrometry; D008875:Middle Aged; D013607:Tablets
chemical_list: D000960:Hypolipidemic Agents; D013607:Tablets; D015248:Gemfibrozil