Table 2.
The plasma pharmacokinetics of budesonide after a single oral dose of MMX®-budesonide tablets containing 9 mg of the drug to fasting and fed subjects. Results are presented as means ± SD, n = 12
| Fasting | Fed | |
|---|---|---|
| Cmax (pg mL−1) | 1428.7 ± 1013.5 | 1039.9 ± 601.4 |
| tlag (h) | 7.4 ± 4.2 | 9.8 ± 3.6 |
| tmax (h) | 16.0 ± 3.4 | 20.7 ± 8.7 |
| AUC48 (pg h −1 mL−1) | 14 814 ± 11254 | 13 486 ± 9369 |
| AUC∞ (pg h −1 mL−1) | 15 503 ± 11340 | 12 512 ± 7569* |
| thalf(h) | 5.4 ± 2.0 | 5.6 ± 2.9* |
| MRT (h) | 19.9 ± 4.6 | 22.3 ± 6.0* |
*
Mean and SD of 10 subjects; Cmax, maximum plasma concentration; tlag, time to detect drug concentration in plasma; tmax, time to achieve Cmax; AUC48, area under the concentration curve from administration to last observed; concentration time t (48 h).; AUC∞, area under the concentration/time curve extrapolated to infinity; thalf, elimination half-life; MRT, mean residence time.