Table 3.
Geometric mean (CV%) pharmacokinetic parameters for tadalafil and its major metabolite following administration of 5, 10 and 20 mg to subjects with end-stage renal failure
| Parameter | Tadalafil 5 mg (Polish; N = 6) | Tadalafil 10 mg (Polish cohort; N = 6) | Tadalafil 10 mg (UK cohort; N = 6) | Tadalafil 20 mg (UK; N = 6) |
|---|---|---|---|---|
| Tadalafil | ||||
| AUC (μg h l−1) | 1633 (63) | 4023 (38) | 13 749 (37) | 18 090 (39) |
| Cmax (μg l−1) | 78.6 (22) | 186 (17) | 394 (21) | 621 (27) |
| tmax (h)* | 3.00 (2.00–4.00) | 4.00 (2.00–4.00) | 2.04 (1.98–3.98) | 2.04 (1.85–2.15) |
| t1/2 (h) | 13.8 (51) | 15.2 (42) | 24.8 (38) | 18.7 (35) |
| CL/F (l h−1) | 3.06 (63) | 2.49 (38) | 0.73 (37) | 1.11 (39) |
| Vz/F (l) | 60.9 (18) | 55.0 (20) | 26.1 (23) | 29.8 (17) |
| Total methylcatechol glucuronide | ||||
| AUC (μg h l−1) | 6051 (34) | 16837 (18) | –† | – |
| AUC (0–last sample time) (μg h l−1) | 5392 (39) | 9983 (29) | 15 981 (35) | 32 229 (25) |
| Cmax (μg l−1) | 64.2 (33) | 109 (36) | 158 (34) | 300 (26) |
| tmax (h)* | 55.3 (27.9–96.0) | 52.4 (24.0–81.7) | 77.5 (29.2–96.1) | 74.1 (30.3–80.8) |
| t1/2 (h) | 51.6 (52) | 66.2 (41) | – | – |
*
Median (min–max).
†
Not calculated. CV%, Coefficient of variation.