Why carry out this study?

Poor adherence to dual antiplatelet therapy or its premature interruption is an important contributor to cardiovascular mortality.

Bioequivalence of the fixed-dose combination compared to simultaneous intake of single drugs in the Chinese population is unknown.

Reference-scaled average bioequivalence approach could be used to establish bioequivalence of drugs with high intrasubject variability.

What was learned from the study?

Fixed-dose combination of acetylsalicylic acid and clopidogrel is bioequivalent to the individual formulations in healthy Chinese patients.

Exposure of subjects to acetylsalicylic acid in fixed-dose combination demonstrated bioequivalence using the reference-scaled average bioequivalence method as the point estimates were within the 0.80–1.25 range, and the upper one-sided 95% CIs of scaled average bioequivalence metric were no greater than 0.

Bioequivalence was also achieved with clopidogrel as the 90% CIs for geometric mean ratios of clopidogrel Cmax, AUClast, and AUC were within the bioequivalence range (0.80–1.25.