Table 2.
Pharmacokinetic parameters of rosuvastatin following a 20 mg oral dose of rosuvastatin alone or in combination with rifampin IV.
| White subjects (n=7) |
Asian subjects (n=8) |
Mean ratio (White to Asian) |
|
|---|---|---|---|
| Rosuvastatin | |||
| Cmax (ng/ml) | 7.6 ± 3.0 | 10.0 ± 4.1 | 0.76 |
| Tmax (h) | 3.0 (1.0–4.0) | 3.1 (1.5–4.0) | -- |
| MAT(h) | 2.70 ± 0.85 | 2.25 ± 0.74 | 1.20 |
| AUC0–∞ (ng·h/ml) | 83.5 ± 32.2 | 92.5 ± 36.2 | 0.90 |
| AUC0–48h (ng·h/ml) | 77.2 ± 31.5 | 86.2 ± 35.5 | 0.90 |
| t1/2 (h) | 16.2 ± 8.5 | 15.2 ± 10.5 | 1.07 |
| CL/F/kg (L/h/kg) | 4.01 ± 1.39 | 3.90 ± 1.25 | 1.22 |
| Vss/F/kg (L/kg) | 59.9 ± 51.7 | 48.9 ± 37.7 | 1.22 |
| Rosuvastatin + rifampin | |||
| Cmax (ng/ml) | 65.0 ± 32.2a | 78.1 ± 42.1a | 0.83 |
| Tmax (h) | 1.5 (0.5–2.5)a | 1.7 (1–3)b | -- |
| MAT(h) | 1.27 ± 0.50b | 0.77 ± 0.42a | 1.65 |
| AUC0–∞ (ng·h/ml) | 281.4 ± 73.3a | 297.2 ± 104.4a | 0.95 |
| AUC0–48h (ng·h/ml) | 278.2 ± 73.2a | 295.2 ± 102.9a | 0.94 |
| t1/2 (h) | 10.3 ± 3.0 | 9.0 ± 2.7 | 1.14 |
| CL/F/kg (L/h/kg) | 1.11 ± 0.32a | 1.21 ± 0.42a | 0.92 |
| Vss/F/kg (L/kg) | 4.90 ± 2.06c | 5.14± 3.00b | 0.95 |
Data were obtained from healthy volunteers in a crossover study design. Values are shown as arithmetic mean ± SD except for Tmax where data are given as median and range. AUC, area under the plasma concentration–time curve; Cmax, maximum plasma concentration; CL/F, oral clearance; MAT, mean absorption time; t1/2, terminal half-life; Tmax, time of observed maximal concentration; Vss/F, oral steady-state volume of distribution.
a
P<0.001 compared with rosuvastatin alone period.
b
P<0.01 compared with rosuvastatin alone period.
c
P<0.05 compared with rosuvastatin alone period.