|
(A) Enalapril prodrug
|
| No |
PK Parameter |
Point Estimate
(Ratio of geometric mean %) |
Lower Limit |
Upper Limit |
CV (%) |
Power |
Result |
| 1 |
AUC 0-last
(ng.hr/ml) |
103.731 |
96.928 |
111.010 |
14.324 |
99.834 |
BE |
| 2 |
AUC0-inf
(ng.hr/ml) |
104.088 |
97.004 |
111.689 |
14.891 |
99.634 |
BE |
| 3 |
Cmax
(ng/ml) |
107.576 |
95.637 |
121.004 |
25.099 |
67.994 |
BE |
|
(B) Enalaprilat (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) |
99.644 |
94.644 |
105.591 |
11.537 |
99.999 |
BE |
| 2 |
AUC0-inf
(ng.hr/ml) |
100.507 |
95.244 |
106.061 |
11.338 |
99.999 |
BE |
| 3 |
Cmax
(ng/ml) |
94.890 |
88.550 |
101.684 |
16.900 |
99.319 |
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 |
AUC 0-last
(nM.hr) |
101.674 |
95.921 |
107.772 |
12.285 |
99.999 |
BE |
| 2 |
AUC0-inf
(nM.hr) |
100.824 |
94.225 |
107.886 |
12.296 |
99.984 |
BE |
| 3 |
Cmax
(nM) |
104.819 |
96.773 |
113.533 |
14.007 |
97.872 |
BE |
