Table 2.
PK parameter | Lisinopril dose
|
||
---|---|---|---|
Low dose 0.1 mg/kg (n=12) | Middle dose 0.2 mg/kg (n=8) | High dose 0.4 mg/kg (n=2) | |
Dose (mg/kg/day) | |||
Median | 0.10 | 0.19 | 0.44 |
Range | (0.03, 0.14) | (0.17, 0.23) | (0.40, 0.48) |
AUC0–24 (ng·h/ml) | |||
GeoMean | 298 | 640 | 702 |
CV% | (46.5) | (28.6) | (66.4) |
CL/F per 70 kg (L/h/70 kg) | |||
GeoMean | 17.9 | 18.6 | 32.8 |
CV% | (61.2) | (34.4) | (54.1) |
Cmax (ng/ml) | |||
GeoMean | 20.9 | 47.7 | 58.0 |
CV% | (41.2) | (25.1) | (41.2) |
Tmax (h) | |||
Median | 5.0 | 5.0 | 4.5 |
Range | (4.0, 8.1) | (4.0, 8.0) | (4.0, 5.0) |
C24 (ng/ml) | |||
GeoMean | 5.4 | 11.2 | 13.1 |
CV% | (51.7) | (64.1) | (212) |
t1/2, terminal (h) | |||
GeoMean | 9.4 | 9.0 | 12.4 |
CV% | (30.1) | (46.1) | (131) |
fe in urine | |||
GeoMean | 0.19 | 0.18 | 0.21 |
CV% | (23.7) | (14.8) | (27.8) |
Renal CL per 70 kg (L/h/70 kg) | |||
GeoMean | 3.4 | 3.4 | 6.8 |
CV% | (60.4) | (46.0) | (94.4) |
PK, pharmacokinetic; AUC, area under the plasma concentration-time curve; CL/F, oral clearance; Cmax, maximum observed concentration; Tmax, time of observed maximal concentration; C24, concentration at 24 hours; t1/2, terminal half-life; fe, fraction of dose excreted in urine during dosing interval; GeoMean, geometric mean; CV%, percent coefficient of variation.