(A) Sildenafil prodrug
|
No |
PK Parameter |
Point Estimate
(Ratio of geometric mean %) |
Lower Limit |
Upper Limit |
CV (%) |
Power |
Result |
1 |
AUC 0-last
(ng.hr/ml) |
105.646 |
97.036 |
115.016 |
19.353 |
95.239 |
BE |
2 |
AUC0-inf
(ng.hr/ml) |
105.376 |
97.370 |
114.039 |
17.970 |
97.577 |
BE |
3 |
Cmax
(ng/ml) |
94.446 |
85.029 |
104.905 |
24.399 |
83.928 |
BE |
(B) N-desmethyl Sildenafil (active metabolite)
|
No |
PK Parameter |
Point Estimate
(Ratio of geometric mean %) |
Lower Limit |
Upper Limit |
CV (%) |
Power |
Result |
1 |
AUC 0-last
(ng.hr/ml) |
111.729 |
106.637 |
117.065 |
10.555 |
99.140 |
BE |
2 |
AUC0-inf
(ng.hr/ml) |
111.320 |
105.610 |
117.339 |
11.923 |
97.932 |
BE |
3 |
Cmax
(ng/ml) |
111.682 |
91.818 |
111.682 |
22.368 |
96.615 |
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) |
92.842 |
87.105 |
98.957 |
14.468 |
98.814 |
BE |
2 |
AUC0-inf
(nM.hr) |
92.705 |
86.912 |
98.884 |
14.637 |
98.533 |
BE |
3 |
Cmax
(nM) |
102.662 |
93.358 |
112.892 |
21.683 |
96.299 |
BE |