TABLE 2.
Parameter Unit | AP (n = 3) | PP (n = 4) | Geometric Mean Ratio (AP/PP, 95% CI) |
---|---|---|---|
C0/dose (μg/ml/mg) | 0.16 ± 0.05 | 0.70 ± 0.39 | 0.29 (0.10–0.82)* |
AUC0-∞/dose (h · ng/ml/mg) | 55.9 ± 2.71 | 107 ± 24.6 | 0.54 (0.42–0.69)* |
CL (liter/h) | 17.9 ± 0.87 | 9.82 ± 2.58 | 1.87 (1.46–2.40)* |
CL (liter/h/kg) | 2.25 ± 0.14 | 1.41 ± 0.38 | 1.63 (1.27–2.10)* |
CLunbound (liter/h) | 1066 ± 111 | 610 ± 100 | 1.76 (1.43–2.18)* |
CLunbound (liter/h/kg) | 156 ± 17.4 | 87.6 ± 12.0 | 1.79 (1.47–2.17)* |
Vss (liter) | 34.2 ± 2.7 | 13.5 ± 7.3 | 2.80 (1.69–4.62)* |
Vss (liter/kg) | 4.33 ± 0.74 | 1.93 ± 1.07 | 2.45 (1.46–4.10)* |
t1/2 (h) | 2.27 ± 1.01 | 2.12 ± 0.33 | 1.02 (0.62–1.67) |
fu (%) | 1.69 ± 0.10 | 1.62 ± 0.34 | 1.06 (0.85–1.32) |
C0/dose, dose-normalized initial plasma concentration; CL, clearance; CLunbound, unbound clearance; Vss, volume of distribution at steady state; t1/2, terminal plasma half-life; fu, unbound in plasma
Significantly different antepartum versus postpartum