TABLE 1.
Parameter Unit | AP (n = 3) | PP (n = 4) | Geometric mean ratio (AP/PP, 95% CI) |
---|---|---|---|
Cmax/dose (ng/ml/mg) | 1.32 ± 0.39 | 4.36 ± 2.23 | 0.32 (0.17–0.61)* |
Tmax (h) | 2.95 ± 2.55 | 1.77 ± 0.51 | 1.34 (0.46–3.90) |
AUC0-∞/dose (h · ng/ml/mg) | 5.90 ± 0.75 | 21.0 ± 12.4 | 0.32 (0.18–0.60)* |
CL/F (liter/h) | 171 ± 23.0 | 61.5 ± 33.5 | 3.14 (1.73–5.70)* |
CL/F (liter/h/kg) | 21.4 ± 0.57 | 9.04 ± 5.22 | 2.73 (1.47–5.10)* |
CL/Funbound (liter/h) | 14,589 ± 3054 | 5393 ± 3325 | 3.04 (1.67–5.51)* |
CL/Funbound (liter/h/kg) | 1817 ± 190 | 791 ± 503 | 2.65 (1.43–4.88) |
t1/2 (h) | 3.43 ± 0.88 | 3.05 ± 1.12 | 1.17 (0.72–1.90) |
F (%) | 10.5 ± 0.89 | 19.0 ± 8.51 | 0.60 (0.38–0.94)* |
fu (%) | 1.19 ± 0.09 | 1.18 ± 0.30 | 1.03 (0.79–1.35) |
Cmax/dose, dose-normalized maximum plasma concentration; Tmax, time to reach maximum plasma concentration; CL/F, total oral plasma clearance; CL/Funbound, unbound oral plasma clearance; t1/2, terminal plasma half-life; F, bioavailability; fu, unbound in plasma
Significantly different antepartum versus postpartum