Table 3.
Noncompartmental analysis of dihydroartemisinin
| Parametera | Median (range) |
P valueb | |
|---|---|---|---|
| Pregnant women (n = 24) | Nonpregnant women (n = 24) | ||
| Body wt (kg) | 51.0 (36.0–58.0) | 47.5 (37.0–78.0) | 0.0737 |
| Total dose (mg/kg) | 6.66 (6.12–7.32) | 6.33 (6.00–7.32) | 0.0135 |
| Cmax 1 (ng/ml) | 366 (113–1,020) | 432 (91.4–1,240) | 0.0696 |
| Cmax 2 (ng/ml) | 595 (73.0–1,160) | 472 (82.4–1,140) | 0.9753 |
| Cmax 3 (ng/ml) | 553 (201–881) | 538 (141–1,280) | 0.6952 |
| CL/F (liter/hr) | 106 (49.0–461) | 81.6 (38.4–236) | 0.0696 |
| CL/F (liter/hr/kg) | 2.14 (1.14–9.04) | 1.74 (0.799–5.50) | 0.1171 |
| V/F (liter) | 170 (60.4–800) | 149 (67.0–457) | 0.3429 |
| V/F (liter/kg) | 3.31 (1.4–15.7) | 3.42 (1.34–9.91) | 0.7105 |
| t1/2 (h) | 1.07 (0.46–2.5) | 1.40 (0.837–2.07) | 0.3753 |
| AUC0–24 (h × ng/ml) | 844 (260–2,170) | 1,220 (396–2,780) | 0.0021 |
| AUC24–48 (h × ng/ml) | 1,100 (195–2,060) | 1,270 (348–3,750) | 0.0909 |
| AUC48–72 (h × ng/ml) | 1,040 (254–2,030) | 1,300 (414–2,580) | 0.1489 |
| AUC48–∞ (h × ng/ml) | 1,050 (260–2,040) | 1,310 (423–2,610) | 0.1489 |
| AUC48–∞/dose [h × ng/ml/(mg/kg)] | 468 (111–878) | 576 (182–1,250) | 0.1171 |
Cmax, maximum observed plasma concentration after dose 1, 2, and 3; CL, elimination clearance; V apparent volume of distribution; t1/2, terminal elimination half-life; AUC0-24, observed area under the plasma concentration-time curve from zero time to 24 h (i.e., 1st dose); AUC24-48, observed area under the plasma concentration-time curve from 24 h to 48 h (i.e., 2nd dose); AUC48-72, observed area under the plasma concentration-time curve from 48 h to 72 h (i.e., 3rd dose); AUC0-∞, predicted area under the plasma concentration time curve after the last dose from zero time to infinity; F, oral bioavailability.
P values are given using the Two-sample Wilcoxon rank-sum (Mann-Whitney) test. Values in boldface are significant.