Table 8. . Pharmacokinetic parameters of healthy human volunteers with the test and reference preparation (n = 30).
Pharmacokinetic parameters |
Enalapril 20 mg |
Enalaprilat |
|||
---|---|---|---|---|---|
Reference preparation | Test preparation | Reference preparation | Test preparation | ||
Cmax (ng/ml) |
Mean |
254.3130 ± 16.1820 |
249.7880 ± 15.4990 |
121.3210 ± 10.7660 |
117.9480 ± 11.5540 |
tmax (h) |
Mean |
0.6810 ± 0.2700 |
0.8060 ± 0.2530 |
2.2500 ± 0.4870 |
2.7000 ± 0.5350 |
AUC 0–72 (ng. h/ml) |
Mean |
317.4790 ± 16.4780 |
315.2940 ± 22.3340 |
1043.1070 ± 50.2960 |
1052.9040 ± 60.5320 |
AUC 0-∞ (ng. h/ml) |
Mean |
319.8340 ± 16.4150 |
317.7470 ± 22.2500 |
1086.8190 ± 53.3050 |
1099.8880 ± 56.1890 |
kel (h-1) |
Mean |
0.4970 ± 0.0210 |
0.4860 ± 0.0200 |
0.0750 ± 0.0040 |
0.0730 ± 0.0050 |
t1/2 (h) |
Mean |
1.3960 ± 0.0590 |
1.4290 ± 0.0580 |
9.2490 ± 0.5320 |
9.5510 ± 0.6190 |
Relative bioavailability (%) | 100 | 99.31 | 100 | 100.94 |
Cmax: Maximum plasma concentration.
tmax: time require to achieve maximum concentration.
AUC0–72: area under the plasma concentration time curve from time zero to 72 h.
AUC0–∞: area under the plasma concentration-time curve from time zero to infinity.
Kel: elimination rate constant.
t1/2: elimination half life.