Table 3.
Delivered Doses and PK Parameters of Velsecorat After a Single Inhaled Dose from Part A (A) and After Inhaled Dosing for 12 Days in Part B (B) Geometric Mean (CV%)
| A: | ||||||||
|---|---|---|---|---|---|---|---|---|
| Delivered Dose (µg) | n | tmax (Hours)e | Cmax (nmol/L) | AUC (nmol·h/L) | t½λz (Hours)f | |||
| 38 | 6 | 0.27 (0.27–0.55)b | 0.039 (33.8)b | NDc | 3.24 (0.681)d | |||
| 187 | 6 | 0.28 (0.25–0.50) | 0.176 (59.3) | 2.36 (26.6)a | 21.9 (3.33)a | |||
| 624 | 6 | 0.25 (0.08–0.52)b | 0.528 (45.4)b | 6.84 (40.9)b | 24.3 (2.60)b | |||
| 1248 | 6 | 0.27 (0.10–0.35) | 0.853 (9.60) | 12.9 (6.80) | 28.1 (8.20) | |||
| 1872 | 6 | 0.42 (0.10–1.02) | 0.992 (30.1) | 17.3 (32.8) | 26.3 (4.95) | |||
| B: | ||||||||
| Delivered Dose (µg) | n | tmax (Hours)e | Cmax (nmol/L) | AUC0–24, ss (nmol·h/L) | t½λz (Hours)f | Racg | ||
| 312 | 6 | 0.08 (0.08–1.02)b | 0.251 (17.8)b | 2.88 (25.3)b | 24.6 (3.56)b | 1.98 (1.64–2.40)b | ||
| 1248 | 6 | 0.25 (0.25–0.25)b | 1.08 (35)b | 10.9 (34.6)b | 25.1 (5.17)b | 1.59 (1.32–1.93)b | ||
| 1872 | 6 | 0.25 (0.25–0.25) | 2.20 (24.2) | 22.4 (23.4) | 31.4 (2.85) | 1.79 (1.50–2.13) | ||
Notes: an=4. bn=5. cn=0. dn=3. eMedian and range. fArithmetic mean (sd). g90% CI, definition AUC0–24, ss/AUC0–24 day 1.
Abbreviation: ND, not determined.