Table 2.
Pharmacokinetic parameters of lisinopril and amlodipine following a single dose of the test and reference formulations under fasting and fed conditions, presented as arithmetic mean ± SD
| Fasting group | Fed group | |||
|---|---|---|---|---|
| T (N = 40) | R (N = 39) | T (N = 38) | R (N = 37) | |
| Lisinopril | ||||
| Cmax(ng/mL) | 55.1 ± 22.7 | 54.8 ± 20.4 | 14.1 ± 4.52 | 14.8 ± 6.80 |
| Tmax (h) | 6.80 ± 1.32 | 6.54 ± 1.14 | 7.34 ± 1.48 | 7.95 ± 1.79 |
| AUC0-t (h × ng/mL) | 950 ± 334 | 940 ± 286 | 385 ± 92.7 | 402 ± 120 |
| AUC0-∞(h × ng/mL) | 1040 ± 353 | 1030 ± 294 | 494 ± 140 | 506 ± 155 |
| T1/2Z (h) | 90.6 ± 35.0 | 92.8 ± 20.7 | 98.6 ± 29.2 | 89.9 ± 27.4 |
| AUC_%Extrap | 9.28 ± 4.81 | 9.26 ± 3.19 | 21.2 ± 6.71 | 20.2 ± 6.52 |
| Amlodipine | ||||
| Cmax(ng/mL) | 2.30 ± 0.574 | 2.31 ± 0.586 | 1.95 ± 0.414 | 1.98 ± 0.398 |
| Tmax (h) | 6.48 ± 1.88 | 6.54 ± 1.80 | 7.97 ± 2.91 | 8.49 ± 2.70 |
| AUC0-t (h × ng/mL) | 118 ± 38.2 | 117 ± 35.5 | 111 ± 26.6 | 120 ± 30.6 |
| AUC0-∞(h × ng/mL) | 128 ± 44.2 | 126 ± 41.0 | 122 ± 34.4 | 131 ± 37.0 |
| T1/2Z (h) | 42.5 ± 6.2 | 42.1 ± 6.66 | 44.3 ± 9.71 | 44.9 ± 8.95 |