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Table 3 Plasma PK Parameters for Navafenterol on Day 1 (PK Population)

From: Navafenterol (AZD8871) in healthy volunteers: safety, tolerability and pharmacokinetics of multiple ascending doses of this novel inhaled, long-acting, dual-pharmacology bronchodilator, in two phase I, randomised, single-blind, placebo-controlled studies

 

Study A

Study B

Navafenterol

300 μg

Navafenterol

600 μg

Navafenterol

900 μg

Navafenterol

300 μg

Navafenterol

600 μg

Navafenterol

900 μg

AUC0–24, pg.h/mL

 n

6

5

6

6

6

6

 Geometric mean

1272

3805

4862

1208

2066

4460

 %GCV

18.69

58.72

15.58

22.89

61.19

18.69

AUClast, pg.h/mL

 n

6

5

6

6

6

6

 Geometric mean

1864

5161

6464

1770

2886

6134

 %GCV

19.20

63.64

16.37

18.83

61.28

21.39

Cmax, pg/mL

 n

6

5

6

6

6

6

 Geometric mean

397.0

991.1

1568

352.4

580.4

1151

 %GCV

28.66

63.45

20.41

28.52

63.64

31.74

tmax, h

 n

6

5

6

6

6

6

 Median

1.50

1.52

1.51

1.01

1.25

1.50

 Min–max

1.00–1.52

1.50–1.55

1.48–1.52

1.00–1.48

0.75–1.50

1.00–2.00

t½λz, h

 n

6

5

6

6

6

6

 Arithmetic mean

50.44

42.89

49.24

52.44

51.75

50.51

 SD

6.796

11.99

9.055

8.207

7.586

6.213

  1. AUC area under the curve, AUC0–24 AUC from 0 to 24 h, AUClast AUC from time 0 to time of the last quantifiable measurable concentration, Cmax maximum plasma concentration, %GCV geometric coefficient of variation, max maximum, min minimum, n number of non-missing observations, PK pharmacokinetic, SD standard deviation, t½λz terminal half-life, tmax time to reach Cmax
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Respiratory Research

ISSN: 1465-993X

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