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. 2013 Oct;57(10):5096–5103. doi: 10.1128/AAC.00683-13

Table 2.

Noncompartmental analysis of lumefantrine in pregnant and nonpregnant patients with uncomplicated P. falciparum malaria

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
a

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.

b

Values are given as the median (range) unless otherwise specified.

c

Based on results for 26 patients.

d

Based on results for 20 patients.