Table 1.
Summary of rosiglitazone and N-desmethylrosiglitazone pharmacokinetic parameter estimates following administration of a single 4 mg dose of rosiglitazone co-administered with febuxostat 120 mg or matching placebo
| Regimen A (febuxostat) | Regimen B (placebo) | |
|---|---|---|
| Rosiglitazone (n= 36) | ||
| Tmax (h)* | 0.50 (0.50–6.00) | 0.50 (0.50–2.00) |
| Cmax (ng ml−1) | 308.6 ± 57.37 | 327.6 ± 67.04 |
| AUC0–tlqc (ng h ml−1) | 1594.9 ± 310.36 | 1564.5 ± 296.97 |
| AUC0–∞ (ng h ml−1) | 1616.0 ± 313.83 | 1584.2 ± 303.82 |
| T1/2 (h) | 4.1 ± 0.66 | 4.0 ± 0.60 |
| CL/F (l h−1) | 2.6 ± 0.49 | 2.6 ± 0.51 |
| Vz/F (l) | 15.0 ± 2.57 | 15.1 ± 2.56 |
| N-Desmethylrosiglitazone (n= 36) | ||
| Tmax (h)* | 8.0 (3.0–16.0) | 8.0 (4.0–14.0) |
| Cmax (ng ml−1) | 81.9 ± 11.87 | 83.0 ± 13.39 |
| AUC0–tlqc (ng h ml−1) | 2499.1 ± 450.32 | 2495.1 ± 434.23 |
| AUC0–∞ (ng h ml−1) | 2541.2 ± 450.24 | 2538.4 ± 436.66 |
| T1/2 (h) | 14.9 ± 2.09 | 15.4 ± 2.45 |
Unless indicated otherwise, all parameters are reported as means ± SD. Abbreviations: Tmax, time to maximal plasma concentration; Cmax, maximal plasma concentration; AUC0–tlqc, area under the curve from time 0 to the time of last quantifiable concentration; AUC0–∞, area under the curve from time 0 to infinity; T1/2, terminal elimination half-life; CL/F, oral clearance; and Vz/F, volume of distribution.
*
Tmax is reported as the median (minimal minus maximal values).