Pharmacokinetic parameters of nintedanib after multiple doses (steady state)
| Nintedanib 50 mg twice daily | Nintedanib 100 mg twice daily | Nintedanib 150 mg twice daily | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Patients without/with ongoing pirfenidone therapy | Alone | Added to ongoing pirfenidone 600 mg three times daily | Patients without/with ongoing pirfenidone therapy | Alone | Added to ongoing pirfenidone 600 mg three times daily | Patients without/with ongoing pirfenidone therapy | Alone | Added to ongoing pirfenidone 600 mg three times daily | |
| AUCτ,ss h·ng·mL-1 | 2/4 | 33.7 (165) | 67.9 (16.7) | 4/3 | 115.0 (32.4) | 86.0 (62.7) | 9/7 | 218 (58.3) | 149 (18.0) |
| Cmax,ss ng·mL-1 | 2/4 | 9.1 (173) | 10.9 (50.3) | 4/3 | 20.0 (64.5) | 13.8 (113.0) | 9/7 | 39.7 (68.1) | 23.5 (27.2) |
| tmax,ss h | 2/4 | 2.4 (1.0–3.9) | 3.9 (1.0–6.0) | 4/3 | 3.4 (2.0–4.1) | 2.0 (2.0–6.0) | 9/7 | 3.9 (1.0–4.0) | 3.9 (1.0–4.0) |
| t1/2,ss h | 0/4 | NA | 25.4 (25.5) | 4/3 | 23.4 (22.4) | 30.5 (20.1) | 9/7 | 27.5 (20.1) | 28.4 (22.7) |
| CL/F,ss mL·min-1 | 2/4 | 24 700 (165.0) | 12 300 (16.7) | 4/3 | 14 500 (32.4) | 19 400 (62.7) | 9/7 | 11 500 (58.3) | 16 800 (18.0) |
| Vz/F,ss L | 0/4 | NA | 27 000 (39.5) | 4/3 | 29 300 (54.7) | 51 200 (76.7) | 9/7 | 27 300 (58.9) | 41 200 (33.8) |
| RA,AUC0–12 | 0/3 | NA | 2.2 (13.8) | 4/3 | 2.0 (91.2) | 1.5 (22.3) | 9/6 | 1.5 (34.9) | 1.7 (92.6) |
| RA,Cmax | 2/4 | 2.3 (26.6) | 1.9 (62.1) | 4/3 | 1.5 (74.5) | 1.4 (35.7) | 9/6 | 1.1 (57.3) | 1.3 (99.8) |