TABLE 2.
Steady-state plasma ABC PK parameters, by treatment and gender, and comparisons
| Plasma ABC PK parameter | Geometric mean (% CV)
|
Geometric least square mean ratio (90% CI)
|
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Treatment A (ABC 300 mg BID regimen)
|
Treatment B (ABC 600 mg QD regimen)
|
|||||||||
| All subjects (n = 27) | Male (n = 18) | Female (n = 9) | All subjects (n = 27) | Male (n = 18) | Female (n = 9) | Treatment B/A (n = 27/27) | Female/male (n = 9/18)
|
|||
| Treatment A | Treatment B | Combinedf | ||||||||
| Original scale | ||||||||||
| AUC0-24(h·μg/ml)a | 7.90 (46) | 6.74 (41) | 10.9 (35) | 8.52 (43) | 7.26 (40) | 11.7 (27) | 1.08 (1.02, 1.15) | 1.59 (1.22, 2.08) | 1.60 (1.25, 2.05) | 1.60 (1.24, 2.05) |
| Cmax (μg/ml) | 1.84 (40) | 1.59 (34) | 2.48 (32) | 3.85 (37) | 3.43 (40) | 4.83 (11) | 2.09 (1.88, 2.32) | 1.55 (1.23, 1.96) | 1.39 (1.11, 1.74) | 1.43 (1.17, 1.76) |
| Cτ (μg/ml) | 0.018 (105) | 0.015 (106) | 0.026 (89) | 0.009 (102)c | 0.008 (103)d | 0.009 (117)e | 0.374 (0.283, 0.494) | 1.68 (0.944, 3.00) | 1.19 (0.495, 2.84) | 1.84 (0.931, 3.64) |
| Wt normalizedb | ||||||||||
| AUC0-24(h·μg/ml)a | 7.88 (46) | 7.04 (41) | 9.88 (48) | 8.50 (43) | 7.58 (41) | 10.7 (38) | 1.08 (1.02, 1.15) | 1.38 (1.03, 1.85) | 1.39 (1.06, 1.82) | 1.38 (1.05, 1.82) |
| Cmax (μg/ml) | 1.84 (41) | 1.66 (35) | 2.25 (45) | 3.83 (35) | 3.58 (39) | 4.39 (23) | 2.09 (1.88, 2.32) | 1.34 (1.03, 1.75) | 1.21 (0.954, 1.52) | 1.24 (0.994, 1.55) |
| Cτ (μg/ml) | 0.018 (101) | 0.016 (98) | 0.024 (103) | 0.008 (107)c | 0.008 (99)d | 0.009 (144)e | 0.372 (0.282, 0.491) | 1.46 (0.827, 2.58) | 1.18 (0.479, 2.90) | 1.60 (0.813, 3.13) |
a
AUC0-24for BID regimen was calculated as 2 × AUC(0 − τ).
b
Weight-adjusted PK parameters were calculated as PK × weight (kg)/70 (kg).
c
n = 21.
d
n = 15.
e
n = 6.
f
Average of treatments A and B for each subject was used.