Abstract
The study aimed to assess the bioequivalence of clopidogrel 75mg generic and reference drugs and to investigate the correlation between pharmacokinetics of active metabolites and its antiplatelet activities. Determination of clopidogrel, carboxylic acid form, and active metabolite were done by liquid chromatography tandem mass spectrometry, and evaluation of platelet function was also investigated by light transmission aggregometer. 20subjects were randomized and assigned in a crossover design to take a single 75-mg oral dose of clopidogrel generic and reference drugs in two periods with washout. Pharmacokinetic parameters C<sub>max</sub>, AUC<sub>0-t</sub>, and AUC<sub>0-inf</sub> of clopidogrel, carboxylic acid form, and active metabolite were analyzed. Bioequivalence could be shown when testing parameters with ANOVA, as 90% confidence intervals were found to be within the acceptance range of 80-125%. For the maximum of platelet aggregation after administration of both products, no significant differences were found. Significant correlation of C<sub>max</sub> of clopidogrel active metabolite and maximum platelet aggregation was found after receiving 0-6 hours of both formulations. The study found bioequivalence of clopidogrel generic and reference drugs. There were also significant correlations between C<sub>max</sub> of clopidogrel active metabolite and maximum platelet aggregation. .
Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
