PK Parameter | Single Dose (20 mg), Mild Renal Impairmenta | |||||
---|---|---|---|---|---|---|
Simulated (n = 140) | Observed (n = 14) | |||||
AUC | Cmax | CLR | AUC | Cmax | CLR | |
µg⋅h/l | µg/l | l/h | µg⋅h/l | µg/l | l/h | |
Geometric mean | 2899 | 279 | 1.46 | 2864 | 252 | 2.25 |
CV (%) | 43 | 29 | 50 | 29 | 29 | 42 |
Ratio of simulated/observed | 1.01 | 1.11 | 0.65 | |||
Success criteria for ratio of simulated/observed | 0.72–1.38 | 0.72–1.38 | 0.63–1.58 | |||
Fold change vs. healthy (90% CI)b | 1.20 (1.09, 1.31) | 0.54 (0.49, 0.60) | 1.11 | 0.93 | ||
- | ||||||
Success criteria for simulated fold change | 0.80–1.81 | 0.30–1.03 |
CI, confidence interval; CV, coefficient of variation.
↵a Greenblatt et al. (2018).
↵b PK parameters in healthy controls used for comparison were obtained from simulations where the mechanistic kidney model incorporating both P-gp and OAT-3 was used to simulate the plasma concentration-time profile of rivaroxaban after a single 20 mg dose.