|
Parameter
|
Unit
|
Tiotropium Respimat 2.5 µg
|
Tiotropium Respimat 5 µg
|
|---|
|
N
|
gMean
|
gCV [%]
|
N
|
gMean
|
gCV [%]
|
|---|
|
AUC0–1,ss
|
pg h/mL
|
3
|
2.08
|
31.7
|
5
|
3.04
|
38.3
|
|
Cmax,ss
|
pg/mL
|
6
|
2.42
|
48.7
|
5
|
4.10
|
97.2
|
|
Cpre,ss
|
pg/mL
| | | |
3
|
1.82
|
13.4
|
|
tmax,ss*
|
min
|
6
|
4.1*
|
3.2–5.0*
|
5
|
4.7*
|
3.5–5.8*
|
|
CLR0–3,ss
|
mL/min
|
3
|
358
|
7.06
|
4
|
278
|
17.9
|
|
RA, Ae0–24
| |
11
|
3.43
|
115
|
12
|
1.71
|
126
|
|
fe0–3,ss
|
%
|
11
|
2.88
|
48.3
|
12
|
2.02
|
65.2
|
|
fe0–24,ss
|
%
|
11
|
10.3
|
62.7
|
12
|
7.39
|
86.3
|
- *Median, minimum–maximum. Ae0–24 = amount of tiotropium that was eliminated unchanged in urine from 0 to 24 h; AUC0–1,ss = area under the curve from 0 to 1 h at steady state; Cmax,ss = maximum measured concentration of the analyte in plasma at steady state; Cpre,ss = pre-dose steady state concentration of the analyte in plasma immediately before administration of the next drug administration; CLR,0–3,ss = renal clearance of tiotropium in plasma from 0 to 3 h at steady state; fe0–3 ss = fraction of tiotropium dose excreted in urine from 0 to 3 h at steady state; fe0–24,ss = fraction of tiotropium dose excreted in urine from 0 to 24 h post-dose at steady state; gCV = geometric coefficient of variation; gMean = geometric mean; RA,0–24 = accumulation ratio from 0 to 24 h; tmax,ss = time from dosing to maximum tiotropium plasma concentration at steady state
