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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.