Table 2.
BE of the DE tablet versus capsule: pharmacokinetic parameters after a single 110-mg dose of the DE tablet or capsule for unconjugated and total dabigatran
| Adjusted gMean | Adjusted gMean ratio (%, tablet/capsule) | Two-sided 90% CI (%) | Intra-individual gCV (%) | |||
|---|---|---|---|---|---|---|
| Tablet | Capsule | Tablet | Capsule | |||
| Unconjugated dabigatran | ||||||
| AUC0–tz (ng h/mL) | 725 (n = 317) | 668 (n = 318) | 108.5 | 101.4–116.0 | 57.0 | 52.3 |
| AUC0–∞ (ng h/mL) | 752 (n = 317) | 693 (n = 318) | 108.4 | 101.9–115.4 | 51.6 | 49.4 |
| Cmax (ng/mL) | 86.3 (n = 318) | 79.2 (n = 318) | 109.0 | 101.8–116.6 | 56.4 | 55.2 |
| Total dabigatran | ||||||
| AUC0–tz (ng h/mL) | 847 (n = 317) | 787 (n = 318) | 107.6 | 100.6–115.1 | 57.3 | 52.5 |
| AUC0–∞ (ng h/mL) | 878 (n = 317) | 814 (n = 318) | 107.8 | 101.3–114.8 | 52.0 | 50.0 |
| Cmax (ng/mL) | 99.8 (n = 318) | 93.5 (n = 318) | 106.7 | 99.5–114.4 | 58.3 | 56.5 |
AUC0–tz area under the concentration–time curve from baseline to last quantifiable data point, AUC0–∞ area under the concentration–time curve from baseline extrapolated to infinity, BE bioequivalence, CI confidence interval, Cmax maximum plasma concentration of dabigatran, DE dabigatran etexilate, gCV geometric coefficient of variation, gMean geometric mean, n number of subjects