Table 1.
Summary of three pharmacokinetics studies and characteristics of patients
| Clinical trial | PENTA 13 | PENTA 15 | ARROW | Total | ||
|---|---|---|---|---|---|---|
| Number of patients | 14 | 18 | 37 | 69 | ||
| Number of pharmacokinetic profiles | 28 | 36 | 74 | 138 | ||
| Steady state | Yes | Yes | Yes | |||
| Age (years) | ||||||
| Mean ± SD | 5.94 ± 3.43 | 1.76 ± 0.76 | 7.61 ± 2.41 | 5.74 ± 3.40 | ||
| Median (range) | 5.10 (2.14–12.84) | 1.93 (0.42–2.81) | 7.70 (3.62–12.54) | 5.66 (0.42–12.84) | ||
| Weight | ||||||
| Mean ± SD | 23.9 ± 13.2 | 11.5 ± 2.3 | 20.3 ± 4.0 | 18.7 ± 8.0 | ||
| Median (range) | 19.2 (14.0–60.9) | 11.6 (7.6–15.8) | 20.5 (14.0–29.8) | 17.6 (7.6–60.9) | ||
| Dosage regimen | ||||||
| Once daily | 16 mg kg−1 | 16 mg kg−1 | 300 mg | 450 mg | 600 mg | |
| Twice daily, a.m. | 8 mg kg−1 | 8 mg kg−1 | 150 mg | 300 mg | 300 mg | |
| Twice daily, p.m. | 8 mg kg−1 | 8 mg kg−1 | 150 mg | 150 mg | 300 mg | |
| Formulation | Tablet and solution | Solution | 300 mg scored tablet | |||