Table 2.
Mean pharmacokinetic (±SD) parameters, comparison of treatment ratios and 90% CIs of natural log (Ln)-transformed parameters following oral administration of 20 mg tadalafil tablet formulation in 24 healthy Indian subjects under fasting.
| Parameter | Test | Reference | Ratio (test/ reference, %) | 90% CI (Lower – upper) | Power | Intra subject variation (% CV) |
|---|---|---|---|---|---|---|
| Cmax (ng/mL) | 396.45 ± 38.16 | 370.82 ± 44.12 | 106.9 | 101.2–110.3 | 0.9991 | 9.53 |
| AUC 0–168 h (h·ng/mL) | 14631.7 ± 1165.6 | 13933.8 ± 978.3 | 105.4 | 100.6–110.9 | 0.9995 | 10.09 |
| AUC 0-inf (h·ng/mL) | 15005.6 ± 1085.1 | 14324.6 ± 1124.2 | 104.7 | 99.2–109.4 | 0.9990 | 11.56 |
| Tmax (h) | 2.37 ± 1.23 | 2.25 ± 1.34 | – | – | – | – |
| t1/2 (h) | 18.6 ± 2.47 | 18.2 ± 2.73 | – | – | – | – |
| Kel (1/h) | 0.037 ± 0.012 | 0.038 ± 0.010 | – | – | – | – |
SD: standard deviation; CI: confidence interval; CV: coefficient of variation; Cmax: maximum plasma concentration; AUC0–168 h: area under the plasma concentration-time curve from 0 h to 168 h; AUC0-inf: area under the plasma concentration-time curve from zero hour to infinity; Tmax: time point of maximum plasma concentration; t1/2: half life of drug elimination during the terminal phase; Kel: elimination rate constant.