Table 2.
Summary of bosentan pharmacokinetic parameters by dosing regimen and age group
| PK parameter | Age group | 2 mg kg –1 b.i.d. | 2 mg kg –1 t.i.d. | Geometric mean ratio (t.i.d./b.i.d.) (95% CI) | ||
|---|---|---|---|---|---|---|
| n | Geometric mean (95% CI) | n | Geometric mean (95% CI) | |||
| AUC 0–24C (h*ng ml –1 ) | Overall | 31 | 8535 (6936, 10 504) | 27 | 7275 (5468, 9679) | 0.85 (0.61, 1.20) |
| <2 years | 9 | 7879 (4783, 12 979) | 8 | 6756 (3761, 12 135) | 0.86 (0.43, 1.72) | |
| ≥2 years | 22 | 8820 (6939, 11 210) | 19 | 7506 (5236, 10 759) | 0.85 (0.57, 1.28) | |
| C maxC (ng ml –1 ) | Overall | 31 | 743 (573, 963) | 27 | 528 (386, 722) | 0.71 (0.48, 1.05) |
| <2 years | 9 | 622 (350, 1106) | 8 | 487 (262, 905) | 0.78 (0.36, 1.69) | |
| ≥2 years | 22 | 799 (587, 1087) | 19 | 546 (366, 814) | 0.68 (0.42, 1.11) | |
| t max a (h) | Overall | 31 | 3.0 (0.0, 7.5) | 27 | 3.0 (1.0, 8.0) | |
| <2 years | 9 | 3.0 (0.0, 3.0) | 8 | 4.0 (1.0, 8.0) | ||
| ≥2 years | 22 | 3.0 (0.0, 7.5) | 19 | 3.0 (1.0, 8.0) | ||
a
Median (range)
PK set. AUC0–24C, area under the concentration–time curve from 0 to 24 h; b.i.d., twice daily; CI, confidence interval; CmaxC, maximum plasma concentration; tmax, time to maximum plasma concentration; PK, pharmacokinetic; t.i.d., three times daily