Table 1.
Summary of overall pharmacokinetic parameters for subjects taking oral artesunate for 7 days
PK parameter | Geometric mean value for subjects given the following dose of AS: |
P valued | ||
---|---|---|---|---|
2 mg/kg | 4 mg/kg | 6 mg/kg | ||
AS on day 0a | ||||
t1/2 (h) | 0.489 | 0.499 | 0.461 | 0.827 |
Tmax (h) | 0.482 | 0.518 | 0.640 | 0.366 |
Cmax (μg/liter) | 83.1 | 237 | 374 | <0.0001 |
AUC0–8 (μg · h/liter) | 91.2 | 279 | 453 | <0.0001 |
MRT (h) | 1.07 | 1.06 | 1.17 | 0.749 |
V/F (liter/kg) | 14.2 | 10.1 | 8.56 | 0.051 |
CL/F (liter/h/kg) | 20.1 | 13.9 | 12.9 | <0.0001 |
DHA on day 0b | ||||
t1/2 (h) | 0.838 | 0.913 | 1.13 | 0.170 |
Tmax (h) | 1.26 | 1.15 | 1.44 | 0.310 |
Cmax (μg/liter) | 554 | 1,515 | 2,129 | <0.0001 |
AUC0–8 (μg · h/liter) | 1,331 | 3,854 | 5,989 | <0.0001 |
MRT (h) | 2.06 | 2.21 | 2.84 | 0.008 |
DHA on day 6c | ||||
t1/2 (h) | 0.799 | 0.851 | 0.843 | 0.186 |
Tmax (h) | 2.08 | 2.11 | 2.17 | 0.555 |
Cmax (μg/liter) | 196 | 497 | 875 | <0.0001 |
AUC0–8 (μg · h/liter) | 481 | 1267 | 2218 | <0.0001 |
MRT (h) | 2.53 | 2.67 | 2.64 | 0.144 |
For the artesunate (AS) pharmacokinetic (PK) parameters for subjects given AS on day 0, 75, 40, and 28 subjects were given 2, 4, and 6 mg/kg of AS, respectively.
For the dihydroartemisinin (DHA) PK values on day 0, 75, 40, and 27 subjects were given 2, 4, and 6 mg/kg of AS, respectively. One subject was excluded from the 6-mg/kg AS group because of an outlier value.
For the DHA PK values on day 0, 73, 38, and 25 patients were given 2, 4, and 6 mg/kg of AS, respectively. The sample size decreased for all three groups because there are no follow-up data for two subjects.
P value for Kruskal-Wallis one-way ANOVA.