Parameter

Non-Fixed Formulation

Fixed Formulation

Artesunate

AUClast (µg.hr/L)

149 ± 70.8

125 ± 88.6 *

Cmax (µg/L)

206 ± 96.7

133 ± 59.3 *

Tmax (hr)

0.510 ± 0.281 (0.500)

0.594 ± 0.793 (0.250)

Dihydroartemisinin

AUClast (µg.hr/L)

1947 ± 621.9

1711 ± 717.3

AUCinf (µg.hr/L)

2039 ± 639.9

1811 ± 725.4

Cmax (µg/L)

902 ± 351

694 ± 283 *

Tmax (hr)

1.06 ± 0.418 (1.00)

1.46 ± 0.827 (1.25)

Mefloquine

AUClast (µg.hr/L)

481403 ± 137378

321836 ± 114473

AUCinf (µg.hr/L)

544350 ± 153692

385899 ± 124168

Cmax (µg/L)

1288 ± 319

715 ± 217

Tmax (hr)

7.10 ± 7.82 (3.98)

37.0 ± 68.2 (15.0) *

Mefloquine, Dose-Normalised to 400 mg Mefloquine

Dose-Normalised AUClast (µg.hr/L)

385122 ± 109902

321836 ± 114473 *

Dose-Normalised AUCinf (µg.hr/L)

435480 ± 122954

385899 ± 124168 *

Dose-Normalised Cmax (µg/L)

1031 ± 256

715 ± 217 *

*p < 0.05 compared to Non-Fixed formulation data; statistical analysis not conducted on non-dose-normalised data.
Table 2: Derived artesunate, dihydroartemisinin and mefloquine pharmacokinetic parameters for healthy volunteers administered artesunate and mefloquine as a Fixed formulation (200 mg artesunate/400 mg mefloquine) and a Non-Fixed formulation (200 mg artesunate + 500 mg mefloquine) (n=24). Data expressed as mean ± standard deviation (median).
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