Table 6.
Summary of individual and derived parameter estimates for the final population pharmacokinetic model for each dose of sildenafil studied (mean±s.d.).
Sildenafil Dose | ||||
---|---|---|---|---|
25 mg (n =224) | 50 mg (n =450) | 100 mg (n =591) | 200 mg (n =115) | |
AUC (ng·h ml−1) | 464±175 | 950±346 | 1963±860 | 5486±1965 |
Cmax (ng ml−1) | 84.4±80.5 | 157±49.2 | 328±237 | 903±287 |
Tmax (h) | 1.09±0.89 | 1.03±0.76 | 1.16±0.99 | 0.99±0.82 |
t1/2 (h) | 3.60±0.72 | 3.67±0.69 | 3.82±0.84 | 3.70±0.73 |
CL/F (l h−1) | 58.2±8.31 | 57.4±8.29 | 56.5±8.60 | 56.9±8.51 |
V/F (l) | 295±29.7 | 297±29.4 | 303±36.4 | 296±29.6 |
Frel | 1.04±0.27 | 1.05±0.25 | 1.05±0.29 | 1.50±0.36 |
ka (h−1) | 12.9±26.1 | 14.9±27.8 | 14.1±25.2 | 20.8±27.4 |
ke (h−1) | 0.200±0.038 | 0.195±0.035 | 0.188±0.038 | 0.194±0.035 |
AUC=area under the curve; CL/F=apparent clearance; V/F=volume of distribution; ka =first-order absorption constant; Cmax =maximum observed concentration; Tmax =time to Cmax; t1/2 =half-life; Frel =relative bioavailability.