Table 3. Summary of pharmacokinetic parameters of total ezetimibe after a single oral administration of fixed-dose combination tablet (rosuvastatin 20 mg / ezetimibe 10 mg) or individual tablets (rosuvastatin 20 mg + ezetimibe 10 mg).
| Parameter (unit) | Test (N=65) | Reference (N=65) | Geometric mean ratio (90% CI) |
|---|---|---|---|
| Cmax (ug/L) | 62.6±26.3 | 70.0±28.2 | 0.886 (0.835–0.940) |
| AUClast (h*ug/L) | 555.8±202.7 | 564.0±202.4 | 0.983 (0.946–1.022) |
| AUCinf (h*ug/L) | 589.6±210.9 | 597.0±211.3 | |
| Tmax (h) | 1.0 (0.5–4.0) | 1.0 (0.5–5.0) | |
| t1/2 (h) | 17.3±10.5 | 16.0±7.4 | |
| CL/F (L/h) | 19.1±6.8 | 18.8±6.6 |
Cmax, maximum plasma concentration; AUClast, area under the plasma concentration-time curve to the last sampling time; AUCinf, area under the plasma concentration time-curve to infinity; tmax, time to Cmax; t1/2, elimination half-life; CL/F, apparent clearance.
Pharmacokinetic parameters are expressed as mean ± SD except for Tmax, which is expressed as median (range).