TABLE 3.
Parameter | Infants/toddlers (ages 3-24 mo)
|
Children (ages 2-11 yr)
|
GMR (90% CI)b (infants/toddlers: children) | Adolescents (ages 12-17 yr)
|
GMR (90% CI)b (infants/toddlers: adolescents) | |||
---|---|---|---|---|---|---|---|---|
na | LSM (95% CI)b | n | LSM (95% CI)b | n | LSM (95% CI)b | |||
Day 1 | ||||||||
AUC0-24 (μg·h/ml) | 7 | 120.20 (88.39, 163.45) | 9 | 96.40 (73.51, 126.42) | 1.25 (0.89, 1.75) | 7 | 77.58 (57.05, 105.50) | 1.55 (1.08, 2.22) |
C1 (μg/ml) | 9 | 17.46 (13.90, 21.93) | 10 | 13.99 (11.27, 17.37) | 1.25 (0.96, 1.62) | 8 | 8.95 (7.03, 11.40) | 1.95 (1.48, 2.57) |
C24 (μg/ml) | 7 | 1.34 (0.87, 2.08) | 9 | 1.09 (0.74, 1.60) | 1.24 (0.76, 2.00) | 7 | 1.26 (0.81, 1.95) | 1.07 (0.64, 1.78) |
β-Phase t1/2 (h) | 7 | 7.79 (2.31)c | 9 | 7.63 (1.61)c | 7 | 10.51 (2.81)c | ||
CL (ml/min/m2) | 7 | 6.05 (4.92, 7.45) | 10 | 7.78 (6.54, 9.26) | 0.78 (0.62, 0.97) | 8 | 6.30 (5.19, 7.66) | 0.96 (0.76, 1.22) |
Day 4 or 3 to 14 time averagedd | ||||||||
AUC0-24 (μg·h/ml) | 8 | 130.29 (105.26, 161.26) | 9 | 115.23 (94.24, 140.89) | 1.13 (0.89, 1.44) | 8 | 117.19 (94.68, 145.04) | 1.11 (0.87, 1.43) |
C1 (μg/ml) | 8 | 17.21 (13.76, 21.54) | 9 | 15.61 (12.64, 19.28) | 1.10 (0.85, 1.42) | 8 | 12.90 (10.31, 16.14) | 1.33 (1.03, 1.74) |
C24 (μg/ml) | 8 | 1.64 (1.10, 2.43) | 9 | 1.46 (1.00, 2.12) | 1.12 (0.72, 1.76) | 8 | 2.15 (1.45, 3.20) | 0.76 (0.48, 1.21) |
β-Phase t1/2 (h) | 8 | 8.80 (2.10)c | 9 | 8.21 (2.35)‡ | 8 | 11.20 (1.71)c |
n, number of patients included in the analysis.
Least square means (LSM) and GMRs are reported for AUC0-24, C1, and C24.
Harmonic means (jackknife standard deviation) are reported for β-phase t1/2.
Time-averaged parameters were determined as the geometric means of all values obtained between days 3 and 14. The day 4 AUC0-24, C1, and β-phase t1/2 for infants/toddlers were compared to day 3 to 14 time-averaged AUC0-24, C1, and β-phase t1/2 for children ages 2 to 11 years. The day 3 to 14 time-averaged C24 for infants/toddlers were compared to the day 3 to 14 time-averaged C24 for children ages 2 to 11 years.