Comparison of PK parameters between simulated and observed data for model verification of the mechanistic kidney model of rivaroxaban after a 10 mg single dose in healthy subjects
Healthy controls are defined as having creatinine clearance > 80 ml/min
| PK Parameter | Single Dose (10 mg), Healthy, P-gp, and OAT3a | |||||
|---|---|---|---|---|---|---|
| Simulated (n = 200) | Observed (n = 20) | |||||
| AUC | Cmax | CLR | AUC | Cmax | CLR | |
| µg⋅h/l | µg/l | l/h | µg⋅h/l | µg/l | l/h | |
| Geometric mean | 1060 | 120 | 3.05 | 892 | 138 | 2.5 |
| CV (%) | 40 | 29 | 55 | 27 | 22 | 26 |
| Ratio of simulated/observed | 1.19 | 0.87 | 1.22 | |||
| Success criteria for ratio of simulated/observed | 0.78–1.29 | 0.81–1.23 | 0.78–1.28 | |||
CI, confidence interval; CV, coefficient of variation.
↵a Mueck et al. (2013).