Table 4.
Mean PK parameters of abediterol in patients with COPD
Parameter (unit) | Abediterol 0.625 μg | Abediterol 2.5 μg | Abediterol 5 μg | Abediterol 10 μg | ||||
---|---|---|---|---|---|---|---|---|
(n = 19) | (n = 19) | (n = 19) | (n = 20) | |||||
mean | (SD) | mean | (SD) | mean | (SD) | mean | (SD) | |
Cmax (pg/mL) | 0.374 | 0.195 | 1.230 | 0.637 | 2.24 | 0.927 | 5.10 | 2.67 |
tmax a (h) | 0.50 | 0.25–8 | 0.50 | 0.22–1.5 | 0.45 | 0.25–1.5 | 0.50 | 0.25–0.75 |
t½ (h) | 27.5b | 9.02 | 17.4c | 6.76 | 16.0d | 5.04 | 15.1e | 3.35 |
AUC0-t (pg.h/mL) | 2.29 | 1.17 | 7.84 | 2.82 | 13.3 | 4.48 | 28.0 | 11.0 |
AUC (pg.h/mL) | 5.95b | 2.66 | 12.5c | 6.01 | 19.7d | 4.48 | 38.1e | 14.1 |
CL/f (L/h) | 119b | 40 | 252c | 135 | 268d | 70.6 | 310e | 161 |
Vz/f (L) | 4345b | 753 | 5736c | 2629 | 6219d | 2675 | 7060e | 5199 |
AUC 0-t area under the concentration-time curve from zero to the last quantifiable time point, AUC area under the concentration-time curve, CL/f total body clearance of drug from plasma after extravascular administration, C max maximum measured plasma concentration, COPD chronic obstructive pulmonary disease, h hour(s), n number of patients with data, PK pharmacokinetic, SD standard deviation, t max time to reach maximum concentration, t ½ terminal elimination half-life, V z /f apparent volume of distribution during terminal phase after extravascular administration
amedian value (min-max), b n = 5, c n = 11, d n = 12, e n = 9