Table 2.
Geometric mean (CV%) pharmacokinetic parameters for tadalafil after administration of a single 10-mg dose
| Parameter | Male (N = 12)* | Female (N = 12)* | Elderly (N = 12) | Young (N = 12) | Healthy subjects (N = 12) | Diabetic (N = 12) | Healthy subjects (renal) (N = 8) | Mild renal impair. (N = 5) | Moderate renal impair. (N = 6) | Healthy subjects (hepatic) (N = 8) | Very mild hepatic impair. (N = 8) | Mild hepatic impair. (N = 8) | Moderate hepatic impair. (N = 8) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AUC (μg h l−1) | 3565 (23) | 4097 (28) | 4881 (32) | 3896 (43) | 4249 (36) | 3458 (38) | 2868 (44) | 6280 (46) | 4911 (50) | 5823 (74) | 3961 (34) | 5760 (52) | 4049 (56) |
| Cmax (μg l−1) | 142 (26) | 140 (21) | 196 (27) | 183 (25) | 193 (22) | 184 (27) | 183 (31) | 217 (21) | 220 (22) | 180 (38) | 133 (21) | 146 (23) | 101 (39) |
| tmax (h)† | 3.5 (1–8) | 3.5 (2–8) | 2.0 (1–4) | 2.5 (1–6) | 2.0 (1–8) | 3.0 (1–4) | 1.0 (0.5–3.0) | 2.0 (2–4) | 2.0 (0.5–3) | 2.50 (0.5–4) | 3.0 (0.5–4) | 2.0 (0.5–6) | 2.5 (0.5–4) |
| t1/2 (h) | 16.6 (21) | 19.8 (26) | 21.6 (39) | 16.9 (29) | 17.1 (27) | 13.8 (33) | 14 (46) | 26 (33) | 22 (43) | 24.2 (53) | 24.7 (43) | 34.9 (48) | 37.8 (62) |
| CL/F (l h−1) | 2.81 (23) | 2.44 (28) | 2.05 (32) | 2.57 (43) | 2.35 (36) | 2.89 (38) | 3.49 (44) | 1.59 (46) | 2.04 (50) | 1.72 (74) | 2.52 (34) | 1.74 (52) | 2.47 (55) |
| Vz/F (l) | 67.2 (16) | 69.8 (19) | 63.9 (25) | 62.5 (17) | 58.2 (23) | 57.4 (18) | 71.8 (40) | 59.2 (16) | 65.9 (17) | 59.9 (30) | 90.1 (19) | 87.5 (25) | 135 (55) |
*
Multiple-dose pharmacokinetics are discussed in text.
†
Median (min–max) data. CV%, Coefficient of variation.