Table 3.
Simulation of Study 1
| Parameter | Abbreviation | Units | Intravenous glycopyrronium | Inhaled glycopyrronium | Inhaled glycopyrronium + activated charcoal | Oral glycopyrronium |
|---|---|---|---|---|---|---|
| Dose | – | μg | 120 | 200 | 200 | 400 |
| Maximal concentration, study report | Cmax | pg ml−1 | 9720 (2230) [n = 18] | 858 (391) [n = 18] | 729 (297) [n = 17] | 78.8 (32.7) [n = 8] |
| Maximal concentration, predicted | Cmax | pg ml−1 | 8090 (1930) | 764 (465) | 761 (476) | 94 (86) |
| Area under the plasma concentration–time curve from time zero to the time of the last measurable concentration, study report* | AUC0–last | h pg ml−1 | 2840 (450) [n = 18] | 1540 (259) [n = 18] | 1360 (309) [n = 17] | 432 (195) [n = 8] |
| Area under the concentration–time curve from 0 to 72 h, predicted | AUC0–72 h | h pg ml−1 | 2910 (887) | 1710 (887) | 1460 (786) | 529 (528) |
| Area under the concentration–time curve from 0 to 72 h, predicted† | AUC0–72 h | h pg ml−1 | – | 1660 (862) | 1410 (781) | – |
| Plasma concentration 24 h after inhalation, study report | C24 h | pg ml−1 | 4.4 (2.4) [n = 20] | 15.6 (3.5) [n = 18] | 13.7 (3.1) [n = 17] | 0.54 (1.5) [n = 8] |
| Plasma concentration 24 h after inhalation, predicted | C24 h | pg ml−1 | 4.8 (3.7) | 14.9 (8.7) | 14.1 (8.4) | 1.3 (1.9) |
*
In general, 24 h for i.v. dose, 72 h for inhaled doses and 8–24 h for oral dose.
†
Calculated by setting concentration at first time point to zero. Data from the study report are arithmetic means (SD) of individual noncompartmental values [n], while predicted data are medians of arithmetic means and SD from simulations with 50 repeated trials and 50 subjects each. i.v., intravenous.