Table 2.
PK Parameters by Treatment Group
Variable | Tiotropium solution | Tiotropium powder | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
1.25 µg | 2.5 µg | 5.0 µg | 18.0 µg | |||||||||
n | gMean | gCV (%) | n | gMean | gCV (%) | n | gMean | gCV (%) | n | gMean | gCV (%) | |
Cmax,ss (pg/mL) | 104 | 2.8 | 53.0 | 110 | 5.1 | 61.8 | 113 | 10.5 | 66.4 | 113 | 12.9 | 64.6 |
Cmax,ss,norm (pg/mL/µg) | 104 | 2.3 | 53.0 | 110 | 2.0 | 61.8 | 113 | 2.1 | 66.4 | 113 | 0.7 | 64.6 |
AUC0–6h,ss (pg · h/mL) | 22 | 10.0 | 25.3 | 76 | 12.8 | 29.9 | 107 | 22.1 | 47.8 | 113 | 28.4 | 52.4 |
AUC0–6h,ss,norm (pg · h/mL/µg) | 22 | 8.0 | 25.3 | 76 | 5.1 | 29.9 | 107 | 4.4 | 47.8 | 113 | 1.6 | 52.4 |
AUC0–1h,ss (pg · h/mL) | 61 | 2.1 | 32.3 | 97 | 3.2 | 44.4 | 112 | 6.1 | 58.3 | 113 | 7.8 | 54.9 |
AUC0–1h,ss,norm (pg · h/mL/µg) | 61 | 1.7 | 32.3 | 97 | 1.3 | 44.4 | 112 | 1.2 | 58.3 | 113 | 0.4 | 54.9 |
Ae0–6h,ss (ng) | 108 | 88.7 | 68.0 | 110 | 177 | 68.0 | 107 | 387 | 65.9 | 109 | 522 | 53.8 |
f0–6h,ss (%) | 108 | 7.09 | 68.0 | 110 | 7.1 | 68.0 | 107 | 7.8 | 65.9 | 109 | 2.9 | 53.8 |
tmax,ss (h)a | 104 | 0.100 | 0.0330–2.00 | 110 | 0.0830 | 0.0330–6.00 | 113 | 0.117 | 0.0330–0.333 | 113 | 0.117 | 0.0330–1.00 |
Ae0–6h,ss, amount of drug excreted in urine from 0 to 6 hours at steady state; AUC0–1h,ss, area under the plasma concentration–time profile from 0 to 1 hour at steady state; AUC0–1h,ss,norm, normalized area under the plasma concentration–time profile from 0 to 6 hours at steady state; AUC0–6h,ss, area under the plasma concentration–time profile from 0 to 6 hours at steady state; AUC0–6h,ss,norm, normalized area under the plasma concentration–time profile from 0 to 6 hours at steady state; Cmax,ss, peak plasma concentration at steady state; Cmax,ss,norm, normalized peak plasma concentration at steady state; f0–6h,ss, fraction of the delivered dose excreted in urine from 0 to 6 hours at steady state; gCV, geometric coefficient of variation; gMean, geometric mean; tmax,ss, time to Cmax at steady state.
Median and range.