|
(A) Sildenafil prodrug
|
| No |
PK Parameter |
Point Estimate
(Ratio of geometric mean %) |
Lower Limit |
Upper Limit |
CV (%) |
Power |
Result |
| 1 |
AUC0-last
(ng.hr/ml) |
113.622 |
107.352 |
120.258 |
13.412 |
87.468 |
BE |
| 2 |
AUC0-inf
(ng.hr/ml) |
112.991 |
106.986 |
119.333 |
12.898 |
92.340 |
BE |
| 3 |
Cmax
(ng/ml) |
108.003 |
95.732 |
121.848 |
28.950 |
63.755 |
BE |
|
(B) N-desmethyl Sildenafil (active metabolite)
|
| No |
PK Parameter |
Point Estimate
(Ratio of geometric mean %) |
Lower Limit |
Upper Limit |
CV (%) |
Power |
Result |
| 1 |
AUC0-last
(ng.hr/ml) |
117.634 |
112.585 |
122.910 |
10.3446 |
74.403 |
BE |
| 2 |
AUC0-inf
(ng.hr/ml) |
115.031 |
110.093 |
120.191 |
10.348 |
93.351 |
BE |
| 3 |
Cmax
(ng/ml) |
108.578 |
98.403 |
119.805 |
23.458 |
76.826 |
BE |
|
(C) Combination (sum of the parent drug and its active metabolite)
|
| No |
PK Parameter |
Point Estimate
(Ratio of geometric mean %) |
Lower Limit |
Upper Limit |
CV (%) |
Power |
Result |
| 1 |
AUC0-last
(nM.hr) |
117.775 |
112.786 |
122.985 |
10.208 |
73.920 |
BE |
| 2 |
AUC0-inf
(nM.hr) |
115.116 |
110.251 |
120.197 |
10.184 |
93.627 |
BE |
| 3 |
Cmax
(nM) |
108.573 |
98.400 |
119.798 |
23.454 |
76.860 |
BE |
