TABLE 3.
Mean PK parameters for subjects treated with 800 and 1,000 mg PA-824
| Dosage group (n) | Arithmetic mean (SD; min, max) PK parameter on:
|
|||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1
|
Day 5
|
Day 8
|
||||||||||
| Cmax (μg/ml) | Tmaxa (h) | AUC0-τd (μg·hr/ml) | Cmax (μg/ml) | Cmin (μg/ml) | Tmax (hr) | AUC0-τ (μg·h/ml) | Cmax (μg/ml) | Cmin (μg/ml) | Tmax (hr) | AUC0-τ (μg·h/ml) | t1/2 (h) | |
| 800 mg (21) | 1.46 (0.60; 0.94, 3.12) | 5.00 (3.00, 16.0) | 25.7 (8.67; 17.9, 47.1) | 2.35b (0.54; 1.54, 3.01) | 1.43b (0.41; 0.94, 2.04) | 4.00b (3.00, 8.00) | 44.9b (10.6; 29.8, 61.2) | 2.92 (0.76; 1.76, 4.37) | 1.74 (0.57; 0.87, 2.90) | 4.00 (2.00, 8.00) | 54.6 (15.0; 32.9, 82.4) | 17.9c (3.03; 12.2, 22.8) |
| 1,000 mg (10) | 1.45 (0.34; 0.74, 2.00) | 4.54 (3.00, 8.00) | 26.0 (6.52; 11.4, 36.6) | 3.13 (0.75; 1.49, 4.13) | 1.86 (0.64; 0.69, 2.80) | 4.00 (2.05, 6.00) | 59.6 (16.5; 25.9, 81.5) | 3.65 (0.85; 2.41, 4.86) | 2.11 (0.60; 1.03, 2.90) | 4.00 (3.00, 8.00) | 69.0 (17.2; 39.3, 96.7) | 18.4 (2.82; 12.0, 22.3) |
a
Tmax is presented as the median (minimum, maximum) value.
b
n = 10. Day 5 sampling was instituted partway through recruitment per a protocol amendment.
c
n = 20. One subject's data did not permit accurate parameter estimation.
d
AUC0-τ, area under the concentration-time curve during the dosing interval.