TABLE 1.
Pharmacokinetic variables of rosuvastatin in 247 healthy volunteers
| Variable | Prospective study (n = 159) | Cohort of previously published studies (n = 88) | Total (n = 247) | |||
|---|---|---|---|---|---|---|
| Geometric mean (geometric CV) | Range | Geometric mean (geometric CV) | Range | Geometric mean (geometric CV) | Range | |
| Dose‐adjusted C max (ng/mL) | 17.8 (66%) | 4.1–103.8 | 16.0 (61%) | 2.8–56.4 | 17.1 (64%) | 2.8–103.8 |
| T max (h) a | 4 | 0.5–8 | 5 | 0.5–7 | 5 | 0.5–8 |
| Dose‐adjusted AUC0‐∞ (ng × h/mL) | 159.6 (52%) | 53.6–535.8 | 142.2 (53%) | 40.2–417.2 | 153.2 (53%) | 40.2–535.8 |
| t ½ (h) | 10.4 (31%) | 4.1–37.8 | 11.9 (48%) | 1.7–45.5 | 10.9 (38%) | 1.7–45.5 |
Rosuvastatin dose in the prospective study was 40 mg, and 10–20 mg in the previously published studies. The AUC0–∞ and C max values from the cohort of previously published studies were adjusted to 40‐mg dose. The observed AUC covered the AUC0–∞ well, except for 2 outliers. The geometric mean (geometric CV) % extrapolated AUC was 3.6% (79%). AUC0–∞, area under the plasma concentration–time curve from 0 hour to infinity; CI, confidence interval; CV, coefficient of variation; C max, peak plasma concentration; T max time to C max; t ½, elimination half‐life.
a
T max data given as median.