(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
BE = Bioequivalent
Table 5: Statistical Result of sildenafil, its active metabolite n-desmethylsildenafil,and their combination under fasting conditions (n = 30).