Table 3.
Statistical comparison of clopidogrel, aspirin, and salicylic acid after single-dose oral administration of FDC capsules or coadministration of individual formulations of clopidogrel 75 mg/aspirin 100 mg (n=53)
| Parameters | Geometric mean ratio (90% CI) | Intraindividual CV (%) |
|---|---|---|
| Clopidogrel | ||
| Cmax | 1.0816 (0.9507, 1.2305) | 41.24 |
| AUClast | 0.9771 (0.8427, 1.1329) | 47.91 |
| AUCinf | 0.9418 (0.8057, 1.1009) | 50.85 |
| Aspirin | ||
| Cmax | 0.9265 (0.8358, 1.0269) | 32.44 |
| AUClast | 0.9825 (0.9265, 1.0418) | 18.16 |
| AUCinf | 1.0123 (0.9124, 1.1232) | 32.76 |
| Salicylic acid | ||
| Cmax | 1.0108 (0.9681, 1.0555) | 13.34 |
| AUClast | 1.0128 (0.9794, 1.0472) | 10.31 |
| AUCinf | 1.0237 (0.9952, 1.0531) | 8.70 |
Note: Bioequivalence criteria are defined as 90% CI of the geometric mean ratios of T/R of between 0.80 and 1.25 for Cmax, AUClast, and AUCinf.
Abbreviations: FDC, fixed-dose combination; CI, confidence interval; CV, coefficient of variance; AUCinf, area under the plasma concentration–time curve from time zero to infinity; Cmax, peak concentration of the drug; T/R, test/reference.