Table 3.
Summary comparison of udenafil pharmacokinetic parameters following oral administration for five days
| Mean (%CV) by Dosing Cohort | |||||
|---|---|---|---|---|---|
|
| |||||
| Parameter (CV%) | 37.5 mg daily (N=6) |
37.5 mg bid (N=6) |
87.5 mg daily (N=6) |
125 mg daily (N=6) |
87.5 mg bid (N=6) |
| Cmax (ng/mL) | 95 (49) | 152 (30) | 277 (39) | 438 (40) | 506 (37) |
| Tmax (hours) | 2.3 (39) | 1.6 (42) | 2.1 (35) | 1.6 (42) | 1.3 (22) |
| AUC0−τ (ng*h/mL) | 834 (48) | 1050 (37) | 2200 (21) | 3420 (53) | 3350 (24) |
| Cavg (ng/mL) | 34.7 (48) | 87.5 (37) | 91.7 (21) | 142.5 (53) | 279.2 (24) |
| CL/F (L/h) | 53.3 (40) | 39.9 (36) | 41.1 (19) | 43.3 (39) | 27.2 (20) |
| Kel (1/h) | 0.0562 (22) | 0.0525 (11) | 0.0553 (7) | 0.0662 (28) | 0.0672 (12) |
|
| |||||
| T½ (h) | 12.3 | 13.2 | 12.5 | 10.5 | 10.3 |
CV: coefficient of variation; bid: twice daily; Cmax = maximum plasma concentration; Tmax = time to Cmax; AUC0−τ = area under the concentration from time 0 to τ where τ = dosing interval (12 or 24 hours); Cavg = AUC0−τ/τ; CL/F = Oral Clearance (Dose/AUC0−τ/bioavailability); T½ = harmonic mean half-life (0.693/mean kel)