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. 2013 Nov 27;54(4):405–414. doi: 10.1002/jcph.215

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.

a

Median and range.