|
Secondary parameters
|
Total
|
Non-pregnant women
|
Pregnant women
|
p-value
|
|---|
|
CMAX (ng/mL)
|
158 [40.6-363]
|
102 [40.6-235]
|
185 [109–363]
|
0.021
|
|
TMAX (hours)
|
2.62 [0.887-4.64]
|
1.48 [0.887-4.18]
|
3.07 [1.65-4.64]
|
0.018
|
|
Half-life (days)
|
23.4 [19.1-33.3]
|
25.7 [20.9-33.3]
|
22.1 [19.1-25.8]
|
0.001
|
|
Day 7 concentration (ng/mL)
|
58.3 [16.6-146]
|
55.4 [16.6-146]
|
60.7 [40.1-103]
|
0.671
|
|
Day 28 concentration (ng/mL)
|
15.9 [4.85-38.6]
|
15.4 [4.85-38.6]
|
16.1 [9.68-26.8]
|
0.840
|
|
AUC0->90 (ng*h/mL)
|
40600 [12400–100000]
|
38000 [12400–100000]
|
42700 [27100–68700]
|
0.799
|
|
AUC48h->90 (ng*h/mL)
|
36400 [10600–90300]
|
35300 [10600–90300]
|
37700 [23500–63200]
|
0.887
|
- Secondary parameters are predicted using the final model and values are presented as median [range]. The p-values are calculated with a Mann–Whitney U-test.
- CMAX is the predicted maximum concentration after the first dose and TMAX is the time to CMAX. Half-life is the estimated terminal elimination half-life. Day 7 and 28 concentrations are the model predicted plasma concentrations of piperaquine at day 7 and 28, respectively. AUC0->90 is the predicted area under the concentration-time curve from time zero extrapolated to day 90. AUC48h->90 is the predicted area under the concentration-time curve from 48 hours extrapolated to day 90.
