Table 1.
Comparison of simulated and observed pharmacokinetic parameters for rosuvastatin after single doses in healthy volunteers
| Rosuvastatin dose | |||||
|---|---|---|---|---|---|
| 10 mg | 20 mg | 40 mg | 80 mg | ||
| Observed GMR (N = 15)a | Cmax (ng/mL) | 3.75 | 6.79 | 10.3 | 30.1 |
| AUC(0–72 h) (ng/mL*h) | 30.7 | 51.5 | 84.4 | 220 | |
|
Mean of simulated trials (range) (N = 15/trial)b |
Cmax (ng/mL) | 4.74 (3.72–6.59) | 9.60 (7.51–13.4) | 19.7 (15.0–27.6) | 41.3 (31.9–58.4) |
| AUC(0–72 h) (ng/mL*h) | 23.4 (19.4–30.2) | 42.7 (39.1–60.9) | 95.8 (79.2–124) | 197 (162–256) | |
AUC, area under the curve; Cmax, maximum concentration; GMR, geometric mean ratio.
a
There were 15 healthy male subjects in the single‐ascending dose study. bTen trials were simulated with 15 healthy male subjects per trial, aged 19–65 years. The mean of the simulated trials represents the arithmetic mean of the 10 geometric means from the simulated trials.