Table 3.
Pharmacokinetics parameters estimated for vardenafil film-coated tablet and vardenafil ODF (F8) from human plasma. Data represent the mean ± SD (n= 3).
| Pharmacokinetics Parameters | Vardapex® (10 mg) Film-Coated Tablet | Vardenafil ODF (F8) |
|---|---|---|
| Ka (min−1) * | 0.0073 ± 0.0001 | 0.0085 ± 0.00027 |
| K (min−1) ** | 0.0065 ± 0.0003 | 0.0066 ± 0.00027 |
| Observed Tmax (min) ** | 120 | 120 |
| Estimated Tmax (min) | 144 ± 1.0 | 130 ± 1.0 |
| Cmax (µg.ml−1) * | 3.56 ± 0.08 | 4.61 ± 0.11 |
| MRT0-ꝏ (min) | 340.9 ± 7.6 | 388.2 ± 6.8 |
| T1/2 (min) | 268.8 ± 6.9 | 317.4 ± 8.2 |
| AUC0-t (µg.ml−1. min) * | 1188 ± 15.87 | 1499 ± 24.70 |
| % Relative bioavailability *** | - | 126.5 ± 3.04 |
* Denotes a statistically significant difference (p < 0.05). ** Observed Tmax was obtained from the time to peak plasma concentration; estimated Tmax was calculated from PK solver software after constructing the log plasma concentration versus time curve by adopting the residual and feathering technique. *** % Relative bioavailability was the total AUC0-24 for F8 divided by AUC0-24 for the conventional film-coated tablet and normalized to 100.