Table 2.
Pharmacokinetic parameters 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)
| Parameter | FDC | Coadministration |
|---|---|---|
| Clopidogrel | ||
| AUClast, ng·h/mL | 6.41±7.70 | 5.95±6.42 |
| AUCinf, ng·h/mL | 6.57±7.75 | 6.46±6.95 |
| Cmax, ng/mL | 3.89±3.82 | 3.73±4.81 |
| Tmax, ha | 0.67 (0.33–2.00) | 0.67 (0.33–3.00) |
| t1/2, h | 5.21±4.35 | 6.31±6.54 |
| Tlast, ha | 12.00 (3.00–24.00) | 12.00 (4.00–24.00) |
| Aspirin | ||
| AUClast, ng·h/mL | 1,777.27±452.17 | 1,822.41±510.13 |
| AUCinf, ng·h/mL | 1,986.54±464.54 | 2,000.69±695.24 |
| Cmax, ng/mL | 783.58±281.68 | 870.60±386.48 |
| Tmax, ha | 4.00 (2.00–6.00) | 4.00 (2.00–6.00) |
| t1/2, h | 0.63±0.36 | 0.65±0.36 |
| Tlast, ha | 6.00 (5.00–10.00) | 6.00 (5.00–10.00) |
| Salicylic acid | ||
| AUClast, ng·h/mL | 47,219.97±13,384.12 | 46,523.63±13,398.18 |
| AUCinf, ng·h/mL | 51,138.82±13,715.45 | 49,788.69±13,335.69 |
| Cmax, ng/mL | 8,620.57±1,715.92 | 8,512.83±1,687.48 |
| Tmax, ha | 5.00 (3.50–6.00) | 5.00 (3.00–6.00) |
| t1/2, h | 2.23±0.44 | 2.15±0.38 |
| Tlast, ha | 12.00 (12.00–24.00) | 12.00 (12.00–24.00) |
Note: Mean ± SD,
a
values expressed as median (range).
Abbreviations: FDC, fixed-dose combination; CV, coefficient of variance; SD, standard deviation; AUC0–t, area under the plasma concentration–time curve from time zero to last observation; AUCinf, area under the plasma concentration–time curve from time zero to infinity; Cmax, peak concentration of the drug; Tlast, time of the last quantifiable concentration; Tmax, time needed to achieve Cmax; t1/2, elimination half-life.