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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