Table 1.
Mean plasma pharmacokinetic parameters of a single 100-mg oral dose of udenafil with and without co-administration of ketoconazole 400 mg
| Parameter | Udenafil alone | Udenafil + ketoconazole | Geometric mean ratio (95% CI) |
|---|---|---|---|
| Cmax (ng ml−1)* | 310.3 (93.8) | 574.4 (124.3) | 1.9 (1.60, 2.27) |
| AUClast (ng h−1 ml−1)* | 2051.5 (379.6) | 6581.2 (1404.5) | 3.20 (2.82, 3.63) |
| AUC∞ (ng h−1 ml−1)* | 2142.6 (395.1) | 6682.0 (1420.5) | 3.11 (2.73, 3.55) |
| t1/2 (h) | 11.9 (1.5) | 12.7 (1.6) | – |
| Tmax (h)†‡ | 1.0 (1.0–2.5) | 1.5 (1.0–4.0) | – |
| CL/F (l h−1)* | 48.7 (12.4) | 15.6 (3.3) | – |
| Metabolic AUC ratio*§ | 1.71 (0.53) | 0.19 (0.09) | – |
*
P < 0.0001, comparison of values based on the paired t-test.
†
P < 0.05, comparison of values based on the Wilcoxon signed rank test.
‡
Tmax values are presented as the median (minimum–maximum).
§
The metabolic AUC ratio of udenafil was calculated as the AUClast of DA-8164 divided by that of udenafil; each AUC was corrected by molecular weight of udenafil and DA-8164. Values represent the arithmetic mean ± SD except for the Tmax.