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, AUC0-∞, and maximum concentration (Cmax) 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) Cmax, AUC0-t and AUC0-∞ of the test formulation (PregobinTM) 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) Cmax, AUC0-t and AUC0- ∞ of the reference formulation (LyricaTM) 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 Cmax, AUC0-t, and AUC0-∞ 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. © 2010, SAGE Publications. All rights reserved.