Pharmacokinetics and Bioavailability of Domestic and Imported Ticlopidine Hydrochloride in Healthy Volunteers

A single oral dose of 500mg domestic or imported Ticlopidine Hydrochloride 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 comcentration time curves of the two preparations were all fitted to a two compartment model with first order absorption and elimination.Cmax of domestic and imported tablets were 1 834±510.7 and 2 019±566.7 μg/L;Tpeak were 1.75±0.75 and 2.00±0.70h;AUC were 6 815±1 493 and 7 008±1 330 μ g/(L·h) respectively.The pharmacokinetic parameters from our studies showed no significant differences between two products(P0.05).The relative bioavailability of domestic to imported tablets was 97.03±8.11%.So it demonstrated that both formulations were bioequivalent.Abstract A single oral dose of 500mg domestic or imported Ticlopidine Hydrochloride 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 comcentration time curves of the two preparations were all fitted to a two compartment model with first order absorption and elimination.Cmax of domestic and imported tablets were 1 834±510.7 and 2 019±566.7μg/L;Tpeak were 1.75 ±0.75 and 2.00±0.70h;AUC were 6 815±1 493 and 7 008±1 330 μg/(L·h) respectively.The pharmacokinetic parameters from our studies showed no significant differences between two products(P0.05).The relative bioavailability of domestic to imported tablets was 97.03±8.11%. So it demonstrated that both formulations were bioequivalent.