Table 2.
Observed vs. predicted pharmacokinetic parameters
| Pharmacokinetic parameter | Cmax (ng/mL) | Tmax (h) | AUC (ng × h/mL) | t 1/2 (h) | ||||
|---|---|---|---|---|---|---|---|---|
| Observed | Predicted | Observed | Predicted | Observed | Predicted | Observed | Predicted | |
| Rivaroxaban 10 mg | 153.7 ± 23.7 | 162.7 ± 26.9 | 3.0 ± 0.5 | 1.5 ± 0.1 | 1,000 ± 161 | 1,208 ± 268 | 5.7 ± 1.8 | 12.5 ± 3.3 |
| Rivaroxaban 10 mg + Ritonavir 600 mg twice daily | 238.0 ± 55.7 | 197.4 ± 32.6 | 4.0 ± 2.2 | 1.6 ± 0.2 | 2,529 ± 425 | 2,761 ± 875 | 6.9 ± 2.2 | 20.2 ± 4.7 |
| Ratio | 1.55 ± 0.43 | 1.21 ± 0.28 | 1.33 ± 0.77 | 1.09 ± 0.14 | 2.53 ± 0.59 | 2.29 ± 0.88 | 1.21 ± 0.53 | 1.62 ± 0.57 |
| Rivaroxaban 10 mg + Darunavir/r 800/100 mg once daily | NA | 190.0 ± 31.2 | NA | 1.7 ± 0.2 | NA | 2,510 ± 685 | NA | 19.9 ± 5.2 |
| Ratio | NA | 1.17 ± 0.27 | NA | 1.16 ± 0.15 | NA | 2.08 ± 0.73 | NA | 1.60 ± 0.60 |
| Darunavir/r 800/100 mg once daily | 6,803 ± 1,618 | 5,432 ± 1,929 | 3.6 ± 1.6 | 3.1 ± 0.5 | 75,780 ± 22,102 | 75,002 ± 56,887 | 14.4 ± 5.2 | 10.9 ± 5.7 |
| Ritonavir 100 mg once daily | 606 ± 281 | 531 ± 280 | 3.1 ± 2.0 | 1.8 ± 0.5 | 5,296 ± 4,664 | 5,470 ± 3,132 | 6.3 ± 1.5 | 5.4 ± 1.4 |
Data are presented as mean +/‐ standard deviation. Observed data are published in ref. 57 for rivaroxaban, refs. 58, 59, 60 for darunavir, and refs.59, 61 for ritonavir.
Cmax, maximal concentration; Tmax, timepoint of the maximal concentration; AUC, area under the curve; t1/2 = elimination half‐life; NA = not applicable.