Table 2.
Pharmacokinetic parameters of acetylsalicylic acid and clopidogrel for test and reference formulations
| Parameters | Acetylsalicylic acid | |||
|---|---|---|---|---|
| Combination | Pooled | Replicate 1 | Replicate 2 | |
| Cmax | ||||
| Number | 162 | 332 | 168 | 164 |
| Mean (SD) (ng/mL) | 790 (504) | 688 (438) | 679 (428) | 698 (449) |
| Geometric mean (ng/mL) | 635 | 532 | 533 | 531 |
| CV (%) | 64 | 64 | 63 | 64 |
| AUClast | ||||
| Number | 162 | 332 | 168 | 164 |
| Mean (SD) (ng h/mL) | 967 (402) | 901 (395) | 881 (375) | 921 (416) |
| Geometric mean (ng h/mL) | 877 | 802 | 794 | 811 |
| CV (%) | 42 | 44 | 43 | 45 |
| AUC | ||||
| Number | 134 | 259 | 132 | 127 |
| Mean (SD) (ng h/mL) | 1020 (397) | 986 (386) | 942 (369) | 1030 (399) |
| Geometric mean (ng h/mL) | 942 | 903 | 856 | 953 |
| CV (%) | 39 | 39 | 39 | 39 |
| Tmax | ||||
| Number | 162 | 332 | 168 | 164 |
| Median (min, max) (h) | 5.00 (3.00–12.00) | 5.50 (2.00–12.00) | 5.50 (2.00–12.00) | 5.50 (3.00–12.00) |
| tlast | ||||
| Number | 162 | 332 | 168 | 164 |
| Median (min, max) (h) | 8.00 (5.00–12.03) | 8.00 (5.50–16.00) | 8.00 (5.50–16.00) | 8.00 (6.00–12.00) |
| t1/2z | ||||
| Number | 134 | 261 | 133 | 128 |
| Mean (SD) (h) | 0.455 (0.165) | 0.471 (0.312) | 0.484 (0.328) | 0.457 (0.294) |
| Geometric mean (h) | 0.433 | 0.428 | 0.436 | 0.421 |
| CV (%) | 36 | 66 | 68 | 64 |
| Clopidogrel | ||||
|---|---|---|---|---|
| Cmax | ||||
| Number | 165 | 334 | 170 | 164 |
| Mean (SD) (pg/mL) | 2390 (3940) | 2130 (3610) | 2120 (3830) | 2150 (3390) |
| Geometric mean (pg/mL) | 1140 | 1040 | 991 | 1090 |
| CV (%) | 164 | 170 | 181 | 158 |
| AUClast | ||||
| Number | 165 | 334 | 170 | 164 |
| Mean (SD) (pg h/mL) | 2810 (4650) | 2980 (4910) | 2890 (4960) | 3080 (4880) |
| Geometric mean (pg h/mL) | 1500 | 1610 | 1530 | 1690 |
| CV (%) | 166 | 165 | 172 | 159 |
| AUC | ||||
| Number | 154 | 281 | 146 | 135 |
| Mean (SD) (pg h/mL) | 3020 (4840) | 3240 (5310) | 3060 (5310) | 3430 (5330) |
| Geometric mean (pg h/mL) | 1670 | 1750 | 1620 | 1910 |
| CV (%) | 160 | 164 | 173 | 155 |
| Tmax | ||||
| Number | 165 | 334 | 170 | 164 |
| Median (min, max) (h) | 0.50 (0.17–3.05) | 0.75 (0.17–12.00) | 0.75 (0.17–12.00) | 0.75 (0.17–4.00) |
| tlast | ||||
| Number | 165 | 334 | 170 | 164 |
| Median (min, max) (h) | 16.00 (4.00–24.02) | 24.00 (3.00–24.05) | 24.00 (6.00–24.03) | 24.00 (3.00–24.05) |
| t1/2z | ||||
| Number | 155 | 283 | 147 | 136 |
| Mean (SD) (h) | 4.94 (1.97) | 5.88 (2.96) | 5.94 (3.31) | 5.81 (2.53) |
| Geometric mean (h) | 4.51 | 5.18 | 5.16 | 5.20 |
AUC area under the plasma concentration versus time, Cmax maximum plasma concentration observed, AUClast area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time, Tmax time to reach Cmax curve, tlast time corresponding to the last concentration above the limit of quantification, t1/2z terminal half-life associated with the terminal slope, CV coefficient of variation