title: A comparative bioavailability study of two formulations of pregabalin in healthy Chilean volunteers.
abstract: OBJECTIVE
  The aim of this study was to compare the pharmacokinetic parameters between two brands of pregabalin in healthy Chilean volunteers.
  
  
  METHODS
  A randomized, single-dose, two-period, two-sequence, crossover study design with a 2-week washout period was conducted in healthy Chilean males. Plasma samples were collected over a 12-hour period after administration of 150 mg pregabalin in each period. A validated ultra-performance liquid chromatography with positive ionization mass spectrometric detection method was used to analyze pregabalin concentration in plasma. Pharmacokinetic parameters were determined using a noncompartmental method. Bioequivalence between the test and reference products was determined when the ratio for the 90% confidence intervals (CIs) of the difference in the means of the log-transformed area under the curve (AUC)(0-t), AUC(0-∞), and maximum concentration (C(max)) of the two products were within 0.80 and 1.25.
  
  
  RESULTS
  The study was carried out on 22 healthy Chilean volunteers. The mean (SD) C(max), AUC(0-t) and AUC(0-∞) of the test formulation (Pregobin™) of pregabalin were 2.10 (0.56) μg/ml, 10.35 (2.00) μgxh/ml and 13.92 (2.74) μgxh/ml, respectively. The mean (SD) C(max), AUC(0-t) and AUC(0-∞) of the reference formulation (Lyrica™) of pregabalin were 2.15 (0.52) μg/ml, 10.31 (1.85) μgxh/ml and 13.78 (2.25) μgxh/ml, respectively. The parametric 90% CIs for C(max), AUC(0-t), and AUC(0-∞) were 0.97-1.13, 1.01-1.04, and 0.98-1.02, respectively.
  
  
  CONCLUSIONS
  These results suggest that both products are bioequivalent and can be used as interchangeable options in the clinical setting.
authors.affiliation: Luis Quiñones, PhD Center of Pharmacological and Toxicological Research (IFT), Molecular and Clinical Pharmacology Program, Faculty of Medicine, Universidad de Chile/ICC, Santiago, Chile.
authors.forename: Luis
authors.initials: L
authors.lastname: Quiñones
authors.forename: Jaime
authors.initials: J
authors.lastname: Sasso
authors.forename: Evelyn
authors.initials: E
authors.lastname: Tamayo
authors.forename: Johanna
authors.initials: J
authors.lastname: Catalán
authors.forename: Juan Paplo
authors.initials: JP
authors.lastname: González
authors.forename: Mario
authors.initials: M
authors.lastname: Escala
authors.forename: Nelson
authors.initials: N
authors.lastname: Varela
authors.forename: Jorge
authors.initials: J
authors.lastname: León
authors.forename: Dante Daniel
authors.initials: DD
authors.lastname: Cáceres
authors.forename: Iván
authors.initials: I
authors.lastname: Saavedra