Table II.
Population n = 16 |
Group BE n = 8 |
Group BD n = 8 |
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Parameter | Mean ± SD | Range | Mean ± SD | Range | Mean ± SD | Range |
AUC0 − t (ng h/mL) | 7004.3 ± 3302.8 | 3694.8 to 11 150.9 | 6126.5 ± 2290.2 | 3694.8 to 10 571.1 | 10 256.1 ± 5849.8 | 2962.0 to 19 680.8 |
AUC0 − ∞ (ng h/mL) | 24 292.2 ± 25 918.5 | 7571.9 to 82 378.1 | 15 953.7 ± 12 849.7 | 7841.8 to 46 569.4 | 31 375.9 ± 24 859.8 | 5179.2 to 82 378.1 |
CL/F (L h/kg) | 0.148 ± 0.083 | 0.024 to 0.264 | 0.168 ± 0.069 | 0.043 to 0.255 | 0.132 ± 0.129 | 0.024 to 0.386 |
λze (1/h) | 0.1102 ± 0.0827 | 0.0203 to 0.2447 | 0.1295 ± 0.0730 | 0.0243 to 0.2274 | 0.1164 ± 0.0773 | 0.0203 to 0.2447 |
t1/2 (h) | 11.3 ± 10.2 | 2.8 to 34.1 | 8.9 ± 8.6 | 3.0 to 28.5 | 10.5 ± 10.3 | 2.8 to 34.1 |
Vz/F (L/kg) | 1.618 ± 0.906 | 0.645 to 3.116 | 1.634 ± 0.899 | 0.645 to 3.116 | 1.195 ± 0.777 | 0.308 to 2.599 |
AUC0 − t — Area under the plasma concentration-time curve from time zero to the last measured time point; AUC0 − ∞ — Area under the plasma concentration-time curve from time zero extrapolated to infinity; CL/F — Relative clearance indexed by bioavailability; λze — Terminal elimination rate constant; t1/2 — Terminal elimination half-life; Vz/F — Volume of distribution indexed by bioavailability.