PHARMACOKINETICS AND BIOEQUIVALENCE ASSESSMENTOF TICLOPIDINE CAPSULE

The pharmacokinetics of ticlopidine was determined following a single oral dose of 500 mg given to each 10 volunteers in an open randomized crossover study. Drug concentration in blood was assayed by HPLC method. The peak levels in blood averaged 2253.3±664.1 and 2054.5±337.6 μg/L at 2.94±1.02 and 2.41±0.65 h, and the mean terminal elimination half-lives were 12.6 ±1.55 and 12.9±2.19 h for domestic capsule and imported tablet respectively; The areas under the drug concentration curve were 16918.2±2673.7 and 17217.3±2851.7 μg·h·L-1 domestic capsule and imported tablet respectively. The concentration-time course after medication conformed to a 2-compartment open model with a first order absorption. The relative bioavailability of domestic capsule of ticlopidine was 98.5±7.82 %. The results of two one-sided tests showed that the two formulation were bioequivalent.