|
Isoniazid
|
<4 years old
|
>4 years old
|
% difference
|
|---|
|
Number of patients enrolled
|
64
|
36
| |
|
Body Weight (median kg - range)
|
9.0 (4.0–15.0)
|
19.0 (13.5–43.0)
| |
|
Age (median months - range)
|
12 (2–48)
|
96 (48–180)
| |
|
Dosage (mean - % CV)
|
25.0 (12.8)
|
27.3 (9.17)
|
p-value: 0.0002a
|
|
CMAX (ug/mL)
|
4.38
|
5.11
|
−14.3
|
|
TMAX (hr)
|
2
|
3
|
−33.3
|
|
CL/F (L/hr)
|
2.48
|
3.88
|
−36.1
|
|
CL/F/BW (L/hr/kg)
|
0.28
|
0.2
|
40
|
|
V/F (L)
|
11.3
|
14.9
|
−23.8
|
|
V/F/BW (L/kg)
|
1.26
|
0.78
|
61.5
|
|
T1/2 (hr)
|
3.17
|
2.66
|
19.2
|
|
AUC0-∞ (hr × ug/mL)
|
20.2
|
25.8
|
−21.8
|
|
AUC0-∞/dosage (hr × ug/mL/(mg/kg))
|
4.48
|
5.26
|
−14.8
|
|
T > MIC (hr)
|
14.2
|
14.5
|
−1.8
|
|
T > MIC/24 h (%)
|
59.3
|
60.3
|
−1.79
|
|
AUC0–24 h > MIC (hr × ug/mL)
|
16.3
|
22
|
−25.8
|
- Apart for dosage with mean and % CV, all values are reported as median (range) or as median estimates for pharmacokinetic parameters. C
MAX
maximum observed plasma concentration after oral administration, T
MAX
observed time to reach CMAX, CL/F oral elimination clearance, CL/F/BW elimination clearance corrected by the median body weight, V/F apparent volume of distribution, V/F/BW apparent volume of distribution corrected by the median body weight, T
1/2
terminal elimination half-life, AUC
0-∞
predicted area under the plasma concentration-time curve after the last dose from zero time to infinity, T > MIC time above the minimum inhibitory concentration, T > MIC/24 h percentage of the time above the minimum inhibitory concentration over the 24 h dose interval, AUC > MIC observed area under the plasma concentration-time curve above the minimum inhibitory concentration. % difference is calculated with the > 4 years group used as the reference. aMann–Whitney T-test
