Table 3 Predicted and observed geometric means of pharmacokinetic parameters of ROF and ROF N-oxide

Hauns et al. (2006) [23]

ROF

0.5, SD

Healthy

30.6 (16.2–44.8)

28.9 (22.9–36.3)

6.6 (4.6–12.8)

6.5 (5.0–8.5)

1.06

1.02

ROF N-oxide

335 (241.5–352.3)

271.1 (217.3–338.1)

9.6 (7.5–16.5)

8.8 (7.1–11.0)

1.24

1.09

Bethke et al. (2007) [24]

ROF

0.25, RD, on day 1

14.2 (9.0–20.5)

18.1 (11.1–29.7)

2.8 (2.5–3.4)

2.9 (2.0–4.3)

0.78

0.97

ROF N-oxide

182.9 (144.3–263.9)

178.6 (115.8–275.2)

4.1 (3.2–5.3)

4.5 (3.5–5.8)

1.02

0.91

ROF

0.5, RD, on day 1

28.3 (18.1–41.1)

35.0 (20.5–59.8)

5.5 (4.5–6.9)

5.3 (4.2–6.6)

0.81

1.04

ROF N-oxide

365.7 (288.6–527.4)

351.3 (235.5–524.0)

8.6 (6.6–11.0)

9.4 (7.5–11.8)

1.04

0.91

ROF

0.25, RD, on day 12

15.6 (9.5–23.9)

17.0 (10.5–27.4)

3.0 (2.7–3.5)

3.1 (2.0–4.6)

0.92

0.97

ROF N-oxide

250.2 (183.6–335.3)

179 (117.4–275.2)

11.6 (9.4–14.9)

10.5 (6.7–16.2)

1.40

1.10

ROF

0.5, RD, on day 12

34.4 (19.9–55.6)

33.7 (19.3–58.7)

6.1 (5.0–7.6)

6.0 (3.8–9.6)

1.02

1.02

ROF N-oxide

500.4 (367.1–670.7)

375.4 (231.5–608.7)

23.1 (17.9–29.7)

21.7 (13.9–33.9)

1.33

1.06

Mey et al. (2011) [25]

ROF

0.5, RD, on day 11

31.2 (19.0–47.8)

35.8 (27.8–46.1)

6.1 (5.0–7.6)

6.9 (4.9–9.6)

0.87

0.97

ROF N-oxide

525.4 (385.5–704.2)

417 (299–582)

27.8 (21.5–35.7)

23.3 (17.3–31.3)

1.26

1.19

Facius et al. (2011) [26]

ROF

0.25, RD, on day 14

COPD

35.2 (16.5–65.3)

43.2 (NR)

4.5 (3.4–6.8)

3.8 (NR)

0.81

1.18

ROF N-oxide

330.1 (4196.7–610.6)

416 (NR)

14.6 (8.9–26.3)

16.4 (NR)

0.79

0.89

ROF

0.5, RD, on day 14

70.5 (62.6–130.7)

65.3 (NR)

6.7 (5.5–8.3)

6.2 (NR)

1.08

1.08

ROF N-oxide

660.2 (393.3–1221.2)

510 (NR)

23.1 (17.9–29.7)

27.6 (NR)

1.29

0.84