BIOEQUIVALENCE STUDY OF CLONAZEPAM 2 mg TABLETS IN COLOMBIAN HEALTHY VOLUNTEERS

In order to determine the bioequivalence of two formulations of clonazepam 2 mg tablets: Sedatril((R))/ Clonazepam MK (Tecnoquimicas S. A., Cali, Colombia) as a test product and Rivotril((R)) (Roche Quimicos e Farmaceuticas 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-infinity), C-max, T-max, t(1/2), and k(e), pharmacokinetic parameters were determined from plasma level-time profiles by a noncompartmental method. ln-trasformed ABC(0-infinity) and C-max 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.