Table 2.
Parameter | 2nd Trimester n = 5 | 3rd Trimester n = 13 | Postpartum n = 8 | Geometric mean 3rd/Post Ratio | Historical Control |
---|---|---|---|---|---|
AUC0–12 (mcg*h/mL) | 4.5 (3.4–10.7) | 8.3 (2.7–31.0) | 5.3 (2.1–16.4) | 1.34 | 6.03 (Schöller-Gyüre et al., 2009) |
C0 (mcg/mL) | 0.26 (0.07–1.05) | 0.60 (<0.005–2.64) | 0.43 (<0.005–1.21) | 2.03 | 0.28 (0.10–0.85) (Boffito et al., 2007) |
Cmax (mcg/mL) | 0.70 (0.44–1.05) | 1.01 (0.26–3.47)* | 0.63 (0.30–1.60) | 1.34 | 0.44 (0.20–1.50) (Boffito et al., 2007) |
Tmax (h) | 2 (0–8) | 4 (2–6) | 4 (1–4) | 1.10 | 4 (1–6) (Schöller-Gyüre et al., 2009) |
C12 (mcg/mL) | 0.36 (0.08–0.75) | 0.48 (0.08–1.94)* | 0.38 (0.07–1.14) | 1.41 | 0.47 (Schöller-Gyüre et al., 2009) |
Cmin (mcg/mL) | 0.25 (0.07–0.75) | 0.45 (<0.005–1.94) | 0.38 (<0.005–1.14) | 1.94 | 0.24 (0.09–0.73) (Boffito et al., 2007) |
CL/F (L/h) | 44 (19–59) | 24 (6–74)* | 38 (12–95) | 0.75 | † |
AUC0-12, area under the concentration vs. time curve from 0 to 12 h; C0, pre-dose concentration; Cmax, maximum concentration; Tmax, time at which maximum concentration occurred; C12, 12 h post-dose concentration; Cmin, minimum observed concentration; Tmin, time at which minimum concentration occurred; CL/F, oral clearance. Data are represented as median (range).
p < 0.05 for 3rd trimester vs. postpartum values using Wilcoxon signed-rank test. For other pharmacokinetic parameters in the 3rd trimester and postpartum, n = 13 and 8, respectively. Historical data AUC0–12 mean was 4.2 mcg*h/mL among non-pregnant adults (Boffito et al., 2007) and 6.03 mcg*h/mL among non-pregnant women (Schöller-Gyüre et al., 2009).
Describes data which was absent in referenced study.