TABLE 2.
Noncompartmental PK parameters of elvucitabine in plasma on day 21 (eight subjects per cohort)
| Parameter | Valuesa for dose of:
|
P valueb | ||
|---|---|---|---|---|
| 5 mg QD | 10 mg QD | 20 mg Q48h | ||
| AUC0-24 (ng·h/ml) | 214 (35.8), 220 (85.9-326) | 435 (45.4), 431 (114-740) | 749 (25.4),* 816 (425-999) | NS*** |
| Cmax (ng/ml) | 23.1 (49.2), 21.7 (5.58-41.3) | 49.9 (63.4), 51.0 (6.16-113) | 108 (37.3,) 110 (52.6-161) | NS*** |
| Tmax (h) | 7.00 (108.0), 4.00 (2.00-24.0) | 3.75 (46.7), 4.00 (1.00-6.98) | 4.00 (0), 4.00 (4.00-4.00) | NS |
| C24 (ng/ml) | 4.38 (22.4),** 4.86 (2.94-5.46) | 9.70 (41.7), 9.73 (4.00-16.8) | 12.0 (26.9), 10.5 (9.58-17.7) | <0.05*** |
| t1/2 (h) | 92.5 (30.9), 79.7 (67.0-132) | 112 (14.4), 112 (85.3-144) | 105 (15.1), 101 (89.5-131) | NS |
a
Values for the dosing regimen are as follows: arithmetic mean (%CV), median (range). *, this AUC is not the AUC during the dosing interval; **, descriptive statistics presented with one subject removed (concentration of 32.8 ng/ml).
b
***, analysis of variance performed using dose-normalized parameters; NS, not statistically significant (P > 0.05).