Resumen

GONZALEZ, FANNY CUESTA et al. Bioequivalence study of clonazepam 2 mg tablets in colombian healthy volunteers. Iatreia [online]. 2007, vol.20, n.3, pp.268-274. ISSN 0121-0793.

In order to determine the bioequivalence of two formulations of clonazepam 2 mg tablets: Sedatril^®/Clonazepam MK (Tecnoquímicas S. A., Cali, Colombia) as a test product and Rivotril^® (Roche Químicos e Farmacêuticas S. A., Rio de Janeiro, Brazil) as a reference product, a bioavailability study was performed in 26 healthy volunteers. Test and reference products were administered under fasting conditions following a single dose, two-sequences, two treatments, crossover randomized design with a 28-day-washout period. Blood samples were obtained from 0 to 96 hours after dosing. Plasma clonazepam levels were determined by a validated high performance liquid chromatography with UV detection method (HPLC/UV). ABC 0-96, ABC 0-∞, Cmax, Tmax, t½, and ke, pharmacokinetic parameters were determined from plasma level-time profiles by a noncompartmental method. ln-trasformed ABC 0-∞ and Cmax were tested for bioequivalence. 90%-confidence intervals for test/reference ratio of these parameters were 87.9% to 103.6% and 84.4% to 104.0%, respectively. These results were within the FDA acceptance range of 80% to 125% and it was concluded that both products were bioequivalent.

Palabras clave : BIOAVAILABILITY; CLONAZEPAM; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PHARMACOKINETICS.

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