TABLE 3.
Parameter for post hoc estimateb | Median value for group (IQR)a |
P value | ||
---|---|---|---|---|
Total | Fasting patients | Fed patients | ||
CL/F (liters/h/kg) | 1.02 (0.802–1.21) | 1.09 (0.745–1.31) | 0.988 (0.867–1.10) | 0.548 |
V/F (liters/kg) | 516 (378–613) | 488 (375–607) | 517 (411–594) | 0.917 |
t1/2 (days) | 19.5 (16.8–21.8) | 19.8 (16.2–21.3) | 19.1 (18.1–21.8) | 0.520 |
Cmax (ng/ml) | 237 (169–347) | 242 (165–319) | 231 (177–395) | 0.663 |
Tmax (h) | 3.57 (3.08–4.27) | 3.36 (2.80–4.20) | 3.64 (3.25–4.16) | 0.520 |
AUCinf (h × μg/ml) | 26.8 (22.7–34.2) | 23.9 (21.6–36.7) | 27.5 (25.2–32.7) | 0.419 |
Day 7 concn (ng/ml) | 29.8 (26.1–35.4) | 26.9 (22.1–42.7) | 30.9 (28.3–34.3) | 0.395 |
Post hoc estimates were calculated as median values with interquartile ranges (IQR) from empirical Bayes estimates, and statistical differences were estimated with a nonparametric Mann-Whitney test.
CL, elimination clearance; F, oral bioavailability; V, apparent total volume of distribution (VC + VP1 + VP2); t1/2, terminal elimination half-life; AUCinf, area under the concentration-time curve from time point 0 to day 138; Cmax, predicted peak concentration; Tmax, predicted time to peak concentration; Day 7 concn, predicted concentration at day 7.