|
Analyte
|
PK parameter#
|
80/480 mg tablet
|
Four standard tablets
|
60/360 mg tablet
|
Three standard tablets
|
|---|
|
Artemether
|
Cmax (ng/mL)
|
113 ± 69.5
|
113 ± 58.9
|
91.2 ± 54.4
|
82.4 ± 42.0
|
|
[n = 58]
|
[n = 59]
|
[n = 57]
|
[n = 60]
|
| |
AUClast (ng·h/mL)
|
389 ± 207
|
408 ± 198
|
280 ± 171
|
267 ± 127
|
|
[n = 58]
|
[n = 59]
|
[n = 57]
|
[n = 60]
|
| |
AUCinf (ng·h/mL)
|
408 ± 209
|
443 ± 202
|
315 ± 173
|
301 ± 123
|
|
[n = 55]
|
[n = 53]
|
[n = 50]
|
[n = 49]
|
| |
Tmax (h)
|
3.00 (1.00;8.00)
|
3.00 (0.75;12.0)
|
3.00 (1.00;6.02)
|
3.00 (0.75;6.00)
|
|
[n = 58]
|
[n = 59]
|
[n = 57]
|
[n = 60]
|
| |
T1/2 (h)
|
2.30 ± 1.11
|
2.51 ± 2.01
|
1.89 ± 0.724
|
1.83 ± 0.834
|
|
[n = 55]
|
[n = 53]
|
[n = 50]
|
[n = 49]
|
|
Lumefantrine
|
Cmax (μg/mL)
|
8.92 ± 3.18
|
9.49 ± 4.41
|
7.26 ± 2.84
|
8.16 ± 2.86
|
|
[n = 58]
|
[n = 59]
|
[n = 57]
|
[n = 59]
|
| |
AUClast (μg·h/mL)
|
236 ± 93.0
|
243 ± 122
|
181 ± 83.9
|
200 ± 85.1
|
|
[n = 58]
|
[n = 58]
|
[n = 56]
|
[n = 56]
|
| |
AUCinf (μg·h/mL)
|
261 ± 106
|
277 ± 146
|
200 ± 96.7
|
221 ± 96.2
|
|
[n = 56]
|
[n = 51]
|
[n = 53]
|
[n = 54]
|
| |
Tmax (h)
|
6.00 (4.00;10.0)
|
6.00 (5.00;12.0)
|
6.00 (5.00;12.0)
|
6.00 (5.00;10.0)
|
|
[n = 58]
|
[n = 59]
|
[n = 57]
|
[n = 59]
|
| |
T1/2 (h)
|
117 ± 37.9
|
120 ± 43.9
|
104 ± 46.5
|
111 ± 61.6
|
|
[n = 58]
|
[n = 56]
|
[n = 56]
|
[n = 56]
|
|
Dihydroartemisinin
|
Cmax (ng/mL)
|
107 ± 53.7
|
110 ± 50.7
|
83.6 ± 41.0
|
78.5 ± 36.8
|
|
[n = 58]
|
[n = 59]
|
[n = 57]
|
[n = 59]
|
| |
AUClast (ng·h/mL)
|
376 ± 126
|
386 ± 130
|
262 ± 98.7
|
256 ± 93.2
|
|
[n = 58]
|
[n = 59]
|
[n = 57]
|
[n = 59]
|
| |
AUCinf (ng·h/mL)
|
397 ± 122
|
397 ± 130
|
290 ± 95.2
|
284 ± 93.6
|
|
[n = 56]
|
[n = 57]
|
[n = 47]
|
[n = 48]
|
| |
Tmax (h)
|
3.00 (1.00;8.00)
|
3.00 (1.50;12.0)
|
3.00 (1.50;10.0)
|
3.00 (1.00;6.00)
|
|
[n = 58]
|
[n = 59]
|
[n = 57]
|
[n = 59]
|
| |
T1/2 (h)
|
1.98 ± 1.00
|
1.87 ± 0.789
|
1.57 ± 0.420
|
1.52 ± 0.365
|
|
[n = 56]
|
[n = 57]
|
[n = 47]
|
[n = 48]
|
- #All PK parameter values are presented as mean ± SD except Tmax which is presented as median (range); number of subjects is given in square brackets.
