A comparative bioavailability study of two formulations of pregabalin in healthy Chilean volunteers

QUINONES, LUIS; SASSO, JAIME; TAMAYO, EVELYN; CATALAN, JOHANNA; GONZALEZ, JUAN PAPLO; ESCALA, MARIO; VARELA, NELSON; LEÓN, JORGE; CACERES, DANTE DANIEL; SAAVEDRA, IVAN

Therapeutic Advances in Chronic Disease

SAGE Publications Inc.

Año: 2010 vol. 1 p. 141 - 141

2040-6223

bjective: 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, AUC0-∞, and maximum concentration (Cmax) of the two products were within 0.80 and 1.25. Results: The study was carried out on 22 heal