Pharmacokinetic Parameter |
Referencea Meanb |
Test Meanb |
Mean Ratio (%) |
Classic CI (%) |
Westlake CI (%) |
Schuirmann Unilateral Double t (%) |
Anderson-Hauck Test |
Power |
Lower |
Upper |
Lower |
Upper |
Lower |
Upper |
Cmax, ng/mL |
|
|
|
|
|
|
|
|
|
|
|
CT with water |
579.29 |
526.11 |
90.82 |
78.93 |
104.49 |
81.41 |
118.59 |
0.0680 |
0.0002 |
0.0678 |
0.8365 |
CT without water |
579.29 |
455.55 |
78.64 |
68.35 |
90.48 |
70.54 |
129.46 |
0.5808 |
0.0000 |
0.5808 |
0.8365 |
AUC0-t, h•ng/mL |
|
|
|
|
|
|
|
|
|
|
|
CT with water |
1714.43 |
1663.47 |
97.03 |
90.94 |
103.52 |
92.18 |
107.82 |
0.0000 |
0.0000 |
0.0000 |
0.9999 |
CT without water |
1714.43 |
1525.19 |
88.96 |
83.38 |
94.92 |
84.61 |
115.39 |
0.0041 |
0.0000 |
0.0041 |
0.9999 |
AUC0-inf, h•ng/mL |
|
|
|
|
|
|
|
|
|
|
|
CT with water |
1800.71 |
1752.02 |
97.30 |
91.50 |
103.46 |
92.67 |
107.33 |
0.0000 |
0.0000 |
0.0000 |
1.0000 |
CT without water |
1800.71 |
1631.88 |
90.62 |
85.23 |
96.36 |
86.41 |
113.59 |
0.0006 |
0.0000 |
0.0006 |
1.0000 |
Criterion |
≥80 |
≤125 |
≥80 |
≤125 |
<0.05 |
<0.05 |
<0.05 |
>0.8 |
CT=chewable sildenafil 100-mg tablet.
aViagra conventional film-coated tablet.
bLeast squares geometric mean. |