PHARMACOKINETICS AND BIOAVAILABILITY OF DOMESTIC REBAMIPIDE TABLET IN HEALTHY VOLUNTEERS

A singal oral dose of 600 mg domestic and imported rebamipide was given to 10 healthy volunteers in a randomized crossover study. Drug concentrations in plasma were determined by HPLC method. The relative bioavailability was studied. The results showed that the plasma concentration-time curve of the two preparations were all fitted to a one-compartment model with first order absorption and elimination. Tmax of domestic and imported tablets were 1.95±0.73 and 1.57±0.55 h;Cmax were 510.8±152.0 and 564.8±187.7μ g/L; T1/2 were 1.75±0.63 and 1.66±0.31 h;AUC were 2506.9±413.9 and 2549.7±513.1 μg·h·L-1 respectively. The pharmacokinetic parameters obtained from our studies showed no significant difference between two products (P0.05). The relative bioavailability of domestic to imported tablets were 99.36±7.87%. So it demonstrated that both formulations were bioequvalence.