Pharmacokinetic Parameter Estimates From the Noncompartmental Analysis of the First Dose According to Study Site
| . | Wang Pha (n = 79),Median (Range) . | Pailin (n = 40),Median (Range) . | P Valuea . |
|---|---|---|---|
| Body weight (kg) | 51.0 (39.0–69.0) | 52.0 (24.0–64.9) | .2636 |
| Total artesunate dose (mg/kg)a | 4.25 (2.88–8.19) | 5.56 (2.86–8.33) | .2777 |
| Artesunate | |||
| Cmax (ng/mL) | 533 (71.1–3330) | 341 (44.4–3610) | .0153 |
| Cmax/dose ([ng/mL]/mg) | 1.92 (0.203–8.83) | 1.35 (0.222–15.6) | .0474 |
| Tmax (h) | 0.500 (0.180–5.03) | 0.983 (0.217–4.98) | .2296 |
| CL/F (L/h) | 645 (290–2950) | 659 (136–2250) | .5699 |
| V/F (L) | 255 (65.8–3720) | 358 (40.1–2430) | .0434 |
| T1/2 (h) | 0.279 (0.0900–2.21) | 0.392 (0.125–2.73) | .0135 |
| AUC0-∞ (h × ng/mL) | 386 (102–1230) | 375 (77.7–1470) | .3006 |
| AUC0-∞/dose ([h × ng/mL]/mg) | 1.55 (0.339–3.45) | 1.51 (0.444–7.35) | .4925 |
| Dihydroartemisinin | |||
| Cmax (ng/mL) | 2430 (583–8160) | 1960 (427–4050) | .0130 |
| Cmax/dose ([ng/mL]/mg) | 14.2 (3.54–31.7) | 10.3 (2.60–27.3) | .0299 |
| Tmax (h) | 1.00 (0.500–5.03) | 1.48 (0.483–4.98) | .8077 |
| CL/F (L/h) | 37.1 (15.0–82.3) | 41.8 (15.8–91.3) | .2442 |
| V/F (L) | 45.9 (18.0–185) | 55.7 (13.1–166) | .0802 |
| T1/2 (h) | 0.842 (0.426–2.77) | 0.836 (0.442–2.08) | .6896 |
| AUC0-∞ (h × ng/mL) | 4540 (1440–19700) | 4680 (1260–12900) | .1630 |
| AUC0-∞/dose ([h × ng/mL]/mg) | 26.9 (12.2–66.7) | 23.9 (7.88–63.5) | .2330 |
| . | Wang Pha (n = 79),Median (Range) . | Pailin (n = 40),Median (Range) . | P Valuea . |
|---|---|---|---|
| Body weight (kg) | 51.0 (39.0–69.0) | 52.0 (24.0–64.9) | .2636 |
| Total artesunate dose (mg/kg)a | 4.25 (2.88–8.19) | 5.56 (2.86–8.33) | .2777 |
| Artesunate | |||
| Cmax (ng/mL) | 533 (71.1–3330) | 341 (44.4–3610) | .0153 |
| Cmax/dose ([ng/mL]/mg) | 1.92 (0.203–8.83) | 1.35 (0.222–15.6) | .0474 |
| Tmax (h) | 0.500 (0.180–5.03) | 0.983 (0.217–4.98) | .2296 |
| CL/F (L/h) | 645 (290–2950) | 659 (136–2250) | .5699 |
| V/F (L) | 255 (65.8–3720) | 358 (40.1–2430) | .0434 |
| T1/2 (h) | 0.279 (0.0900–2.21) | 0.392 (0.125–2.73) | .0135 |
| AUC0-∞ (h × ng/mL) | 386 (102–1230) | 375 (77.7–1470) | .3006 |
| AUC0-∞/dose ([h × ng/mL]/mg) | 1.55 (0.339–3.45) | 1.51 (0.444–7.35) | .4925 |
| Dihydroartemisinin | |||
| Cmax (ng/mL) | 2430 (583–8160) | 1960 (427–4050) | .0130 |
| Cmax/dose ([ng/mL]/mg) | 14.2 (3.54–31.7) | 10.3 (2.60–27.3) | .0299 |
| Tmax (h) | 1.00 (0.500–5.03) | 1.48 (0.483–4.98) | .8077 |
| CL/F (L/h) | 37.1 (15.0–82.3) | 41.8 (15.8–91.3) | .2442 |
| V/F (L) | 45.9 (18.0–185) | 55.7 (13.1–166) | .0802 |
| T1/2 (h) | 0.842 (0.426–2.77) | 0.836 (0.442–2.08) | .6896 |
| AUC0-∞ (h × ng/mL) | 4540 (1440–19700) | 4680 (1260–12900) | .1630 |
| AUC0-∞/dose ([h × ng/mL]/mg) | 26.9 (12.2–66.7) | 23.9 (7.88–63.5) | .2330 |
Abbreviations: AUC0-∞, predicted area under the plasma concentration time curve after the first dose from zero time to infinity; CL, elimination clearance; Cmax, maximum observed plasma concentration after oral administration; F oral bioavailability; Tmax, observed time to reach Cmax; T1/2, terminal elimination half-life; V, apparent volume of distribution.
aP values are given using the Mann-Whitney test.
b The median dose of artesunate is lower in Pailin compared to Wang Pha because of discontinuation of the 8 mg/kg/d arm in Pailin (see Figure 1).
Pharmacokinetic Parameter Estimates From the Noncompartmental Analysis of the First Dose According to Study Site
| . | Wang Pha (n = 79),Median (Range) . | Pailin (n = 40),Median (Range) . | P Valuea . |
|---|---|---|---|
| Body weight (kg) | 51.0 (39.0–69.0) | 52.0 (24.0–64.9) | .2636 |
| Total artesunate dose (mg/kg)a | 4.25 (2.88–8.19) | 5.56 (2.86–8.33) | .2777 |
| Artesunate | |||
| Cmax (ng/mL) | 533 (71.1–3330) | 341 (44.4–3610) | .0153 |
| Cmax/dose ([ng/mL]/mg) | 1.92 (0.203–8.83) | 1.35 (0.222–15.6) | .0474 |
| Tmax (h) | 0.500 (0.180–5.03) | 0.983 (0.217–4.98) | .2296 |
| CL/F (L/h) | 645 (290–2950) | 659 (136–2250) | .5699 |
| V/F (L) | 255 (65.8–3720) | 358 (40.1–2430) | .0434 |
| T1/2 (h) | 0.279 (0.0900–2.21) | 0.392 (0.125–2.73) | .0135 |
| AUC0-∞ (h × ng/mL) | 386 (102–1230) | 375 (77.7–1470) | .3006 |
| AUC0-∞/dose ([h × ng/mL]/mg) | 1.55 (0.339–3.45) | 1.51 (0.444–7.35) | .4925 |
| Dihydroartemisinin | |||
| Cmax (ng/mL) | 2430 (583–8160) | 1960 (427–4050) | .0130 |
| Cmax/dose ([ng/mL]/mg) | 14.2 (3.54–31.7) | 10.3 (2.60–27.3) | .0299 |
| Tmax (h) | 1.00 (0.500–5.03) | 1.48 (0.483–4.98) | .8077 |
| CL/F (L/h) | 37.1 (15.0–82.3) | 41.8 (15.8–91.3) | .2442 |
| V/F (L) | 45.9 (18.0–185) | 55.7 (13.1–166) | .0802 |
| T1/2 (h) | 0.842 (0.426–2.77) | 0.836 (0.442–2.08) | .6896 |
| AUC0-∞ (h × ng/mL) | 4540 (1440–19700) | 4680 (1260–12900) | .1630 |
| AUC0-∞/dose ([h × ng/mL]/mg) | 26.9 (12.2–66.7) | 23.9 (7.88–63.5) | .2330 |
| . | Wang Pha (n = 79),Median (Range) . | Pailin (n = 40),Median (Range) . | P Valuea . |
|---|---|---|---|
| Body weight (kg) | 51.0 (39.0–69.0) | 52.0 (24.0–64.9) | .2636 |
| Total artesunate dose (mg/kg)a | 4.25 (2.88–8.19) | 5.56 (2.86–8.33) | .2777 |
| Artesunate | |||
| Cmax (ng/mL) | 533 (71.1–3330) | 341 (44.4–3610) | .0153 |
| Cmax/dose ([ng/mL]/mg) | 1.92 (0.203–8.83) | 1.35 (0.222–15.6) | .0474 |
| Tmax (h) | 0.500 (0.180–5.03) | 0.983 (0.217–4.98) | .2296 |
| CL/F (L/h) | 645 (290–2950) | 659 (136–2250) | .5699 |
| V/F (L) | 255 (65.8–3720) | 358 (40.1–2430) | .0434 |
| T1/2 (h) | 0.279 (0.0900–2.21) | 0.392 (0.125–2.73) | .0135 |
| AUC0-∞ (h × ng/mL) | 386 (102–1230) | 375 (77.7–1470) | .3006 |
| AUC0-∞/dose ([h × ng/mL]/mg) | 1.55 (0.339–3.45) | 1.51 (0.444–7.35) | .4925 |
| Dihydroartemisinin | |||
| Cmax (ng/mL) | 2430 (583–8160) | 1960 (427–4050) | .0130 |
| Cmax/dose ([ng/mL]/mg) | 14.2 (3.54–31.7) | 10.3 (2.60–27.3) | .0299 |
| Tmax (h) | 1.00 (0.500–5.03) | 1.48 (0.483–4.98) | .8077 |
| CL/F (L/h) | 37.1 (15.0–82.3) | 41.8 (15.8–91.3) | .2442 |
| V/F (L) | 45.9 (18.0–185) | 55.7 (13.1–166) | .0802 |
| T1/2 (h) | 0.842 (0.426–2.77) | 0.836 (0.442–2.08) | .6896 |
| AUC0-∞ (h × ng/mL) | 4540 (1440–19700) | 4680 (1260–12900) | .1630 |
| AUC0-∞/dose ([h × ng/mL]/mg) | 26.9 (12.2–66.7) | 23.9 (7.88–63.5) | .2330 |
Abbreviations: AUC0-∞, predicted area under the plasma concentration time curve after the first dose from zero time to infinity; CL, elimination clearance; Cmax, maximum observed plasma concentration after oral administration; F oral bioavailability; Tmax, observed time to reach Cmax; T1/2, terminal elimination half-life; V, apparent volume of distribution.
aP values are given using the Mann-Whitney test.
b The median dose of artesunate is lower in Pailin compared to Wang Pha because of discontinuation of the 8 mg/kg/d arm in Pailin (see Figure 1).
This PDF is available to Subscribers Only
View Article Abstract & Purchase OptionsFor full access to this pdf, sign in to an existing account, or purchase an annual subscription.
