Table 5.
n | Age | Weight (kg) | Dose (μg/kg) | Route | Cmax (ng/mL) | CL (mL/min/kg) | t1/2 (min) | V(ss) (mL/kg) | Comp | No of samples | Lab method | Remarks | Ref. |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
8 | 5.1 ± 2.9 weeks | 3.7 ± 0.7 | 5 | IV, 1 min | 24.2 ± 10.2* | 90.5 ± 36.8* | 5.4 ± 1.8 | 452.7 ± 144.8* | non | 10/1h | GC-MS [192] | Age < 2 months | [150] |
6 | 7.6 ± 4.3 months | 8.7 ± 2.6 | 5 | IV, 1 min | 25.4 ± 3.7* | 92.1 ± 25.8* | 3.4 ± 1.2 | 307.9 ± 89.2 | non | 10/1h | GC-MS [192] | Age 2 months to 2 years | [150] |
7 | 4.6 ± 1.8 years | 16.5 ± 4.7 | 5 | IV, 1 min | 34.8 ± 8.2 | 76.1 ± 22.4 | 3.6 ± 1.8 | 240.1 ± 130.5 | non | 13/4h | GC-MS [192, 193] | Age 2 to 7 years; Metabolite GR90291 (n=7): Cmax 5.8 ± 1.1 ng/mL, t1/2 81.0 ± 44.6 min | [150] |
6 | 9.7 ± 2.3 years | 36.3 ± 9.7 | 5 | IV, 1 min | 42.5 ± 13.7 | 59.7 ± 22.5 | 5.3 ± 1.4 | 248.9 ± 91.4 | non | 13/4h | GC-MS [192, 193] | Age 7 to 13 years; Metabolite GR90291 (n=7): Cmax 6.9 ± 2.1 ng/mL, t1/2 64.2 ± 25.7 min | [150] |
4 | 14.0 ± 1.2 years | 58.6 ± 25.7 | 5 | IV, 1 min | 35.0 ± 10.2 | 57.2 ± 21.1 | 3.7 ± 1.1 | 223.2 ± 30.6 | non | 13/4h | GC-MS [192, 193] | Age 13 to 16 years; Metabolite GR90291 (n=3): Cmax 6.5 ± 1.0 ng/mL, t1/2 55.5 ± 26.9 min | [150] |
3 | 16.3 ± 0.6 years | 60.6 ± 6.9 | 5 | IV, 1 min | 42.7 ± 12.9 | 46.5 ± 2.1 | 5.7 ± 0.7 | 242.5 ± 109.2 | non | 13/4h | GC-MS [192, 193] | Age 16 to 18 years; Metabolite GR90291 (n=3): Cmax 10.7 ± 6.6 ng/mL, t1/2 103.2 ± 75.4 min | [150] |
| |||||||||||||
12 | 6.3 ± 4.6 years | 27.0 ± 20 | 5 | IV, 1 min | 38.7 ± 9.6 | 8.2 ± 3 | 234.5 ± 105.5 | 2 | 9/0.75h | HPLC | Pre-CPB | [171] | |
12 | 6.3 ± 4.6 years | 27.0 ± 20 | 5 | IV, 1 min | 46.8 ± 14* | 6.9 ± 2.6 | 235.3 ± 110.2 | 2 | 9/0.75h | HPLC | Post-CPB (same cohort) | [171] | |
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26 | 1.77a) (0.08–9.25) years | 10.5a) (3.1–39.8) | max. 48/h | IV, 194a) (19–1236) min | 68.3 | 2 | > 8 | HPLC | Pop-PK (post-CPB n=21) | [152] | |||
| |||||||||||||
9 | 2.19 (0.5–4.0) years | 11.4 (6.4–14.7) | 15.8 ± 12.3/h;(entire study: 65.0 ± 32.6 μg/kg) | IV, cont.(entire study: 218 ± 77.9 min) | 13.8 ± 7.80 | 21.4 | 4.02 | 124 | 1 | 3a) (1–9) | GC-MS [171] | Pop-PK, pre-CPB; | [172] |
9 | 2.19 (0.5–4.0) years | 11.4 (6.4–14.7) | 20.3 ± 7.2/h | IV, cont. | 12.7 ± 6.39 | 21.4 | 9.65 | 298 | 1 | 3a) (1–5) | GC-MS [171] | Pop-PK, during CPB (same cohort) | [172] |
9 | 2.19 (0.5–4.0) years | 11.4 (6.4–14.7) | 19.3 ± 10.5/h | IV, cont. | 11.7 ± 7.03 | 21.4 | 9.65 | 298 | 1 | 7a) (3–8) | GC-MS [171] | Pop-PK, post-CPB (same cohort) | [172] |
| |||||||||||||
7 | 0.74 (0.3–1.0) years | 7.59 (6.6–9.6) | IV, cont. | 2.99 L/min/70 kg | 16.23 L/70 kg | 2 | Total: 77 | GC-MS [192] | Pop-PK; final model parameter estimates | [153] |
median data (range)
Reported statistical significance is indicated as follows:
p < 0.05,
p < 0.005,
p < 0.001.