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Table 3 Summary of glycopyrronium pharmacokinetic parameters (mITT population)

From: Randomized study of the safety, pharmacokinetics, and bronchodilatory efficacy of a proprietary glycopyrronium metered-dose inhaler in study patients with chronic obstructive pulmonary disease

Parameter

Arithmetic mean (CV%)

 

GP MDI 14.4 μg

GP MDI 28.4 μg

GP MDI 57.6 μg

GP MDI 115.2 μg

N

18

18

20

20

AUC0–24 (pg•h/mL)

34.5 (101.2)

120 (67.2)

202 (74.5)

498 (82.0)

AUC0–12 (pg•h/mL)

31.9 (88.8)

89.9 (57.7)

163 (70.6)

398 (79.8)

AUC12–24 (pg•h/mL)

4.34 (250.5)b

32.0 (147.0)d

41.0 (91.3)e

102 (100.9)f

AUC0-tlast (pg•h/mL)

30.7 (112.5)

113 (74.4)

196 (78.8)

491 (84.4)

AUC0-inf (pg•h/mL)

66.2 (72.2)c

127 (68.7)b

252 (70.8)e

598 (84.0)f

Cmax (pg/mL)

15.6 (72.0)

27.3 (51.5)

62.9 (72.3)

160 (73.8)

tmax a (h)

0.333 (0.0330, 0.350)

0.100 (0.0330, 0.383)

0.100 (0.0330, 0.917)

0.100 (0.0330, 0.933)

t1/2 (h)

5.09 (82.0)c

6.28 (62.6)b

8.76 (59.4)e

9.61 (36.6)f

CL/F (L/h)

416 (77.0)c

494 (89.6)b

510 (81.3)e

422 (75.6)f

Vz/F (L)

1995 (32.2)c

3320 (56.9)b

4627 (50.9)e

4697 (49.7)f

  1. aMedian (Min, Max); bn = 11; cn = 10; dn = 12; en = 19; fn = 16.
  2. AUCx-y = area under the concentration-time curve from time x to time y; CL/F = apparent oral clearance; Cmax = maximum plasma concentration; CV% = coefficient of variation; GP MDI = glycopyrronium metered-dose inhaler; t1/2 = apparent terminal elimination half-life; tmax = time to maximum concentration; Vz/F = apparent volume of distribution; mITT=modified intention to treat.