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Table 2 Summary statistics of PK parameters

From: Evaluation of two novel tablet formulations of artemether-lumefantrine (Coartem®) for bioequivalence in a randomized, open-label, two-period study

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]

  1. #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.