Table 2.
Parametera | Result (range)b for: |
P value | |
---|---|---|---|
Pregnant women (n = 25) | Nonpregnant women (n = 17) | ||
Total dose (mg/kg) | 51.4 (38.9–65.5)c | 58.8 (45.7–72.0) | 0.010 |
Tmax (h) | 4.00 (0.0833–12.1)c | 6.00 (1.00–14.0) | 0.032 |
Cmax(μg/ml) | 9.19 (0.485–22.4)c | 8.88 (4.50–17.0) | 0.747 |
CL/F (liters/h) | 4.40 (1.54–36.3) | 4.63 (2.46–9.87) | 0.828 |
CL/F (liters/h/kg) | 0.0829 (0.0288–0.825) | 0.0942 (0.0503–0.224) | 0.377 |
V/F (liters) | 414 (63.4–2,510) | 421 (227–1,330) | 0.450 |
V/F (liters/kg) | 6.90 (1.22–57.1) | 7.65 (4.63–30.3) | 0.148 |
T1/2 (h) | 53.5 (28.5–79.4) | 65.7 (48.2–93.7) | 0.003 |
AUC72–LAST (h · μg/ml) | 177 (63.0–1,130) | 163 (86.1–4,400) | 0.691 |
AUC72–∞ (h · μg/ml) | 189 (64.7–1,170) | 197 (99.0–544) | 0.949 |
AUC0–LAST (h · μg/ml) | 632 (77.7–1,840) | 591 (270–1,080) | 0.729 |
AUC0–∞ (h · μg/ml) | 654 (79.4–1,870) | 621 (292–1,170) | 0.828 |
AUC0–∞/dose (h · μg/ml/[mg/kg]) | 12.1 (1.21–34.7) | 10.6 (4.46–19.9) | 0.377 |
Day 7 concn (ng/ml) | 488 (30.7–3,550)d | 720 (339–2,150) | 0.128 |
Cmax, maximum observed plasma concentration after the last dose; TMAX LAST, observed time after last dose to reach Cmax; CL, elimination clearance; V, apparent volume of distribution; T1/2, terminal elimination half-life; AUC72–LAST, observed area under the plasma concentration-time curve from 72 h to the last observed concentration; AUC72–∞, predicted area under the plasma concentration time curve from 72 h to infinity; AUC0–LAST, observed area under the plasma concentration-time curve from zero time to the last observed concentration; AUC0–∞, predicted area under the plasma concentration time curve from zero time to infinity; Day 7 concn, observed day 7 concentration after repeated drug administration; F, oral bioavailability.
Values are given as the median (range) unless otherwise specified.
Based on results for 26 patients.
Based on results for 20 patients.