TABLE 5

Pharmacokinetic parameters and analysis for artemether, dihydroartemisinin (metabolite), and lumefantrine following administration of artemether-lumefantrine with or without tafenoquined

Analyte and treatment group or parameterGeometric mean AUC0–τ (ng · h/ml)Geometric mean AUC0–last (ng · h/ml)Geometric mean Cmax (ng/ml)Geometric mean t1/2 (h)Median Tmax (h) (range)
Artemether
    TQ + AL (n = 22)186.2a38.823.21.5a2.0 (1.0–6.0)c
    AL (n = 21)103.0b37.722.42.0b2.0 (1.0–8.0)
    CVb (%)62.8216.280.976.3
    Ratio (90% CI)1.81 (1.06, 3.10)1.03 (0.52, 2.04)1.03 (0.71, 1.49)0.76 (0.41, 1.44)
Dihydroartemisinin (metabolite)
    TQ + AL (n = 22)226.8239.386.81.8c1.9 (2.0–6.0)
    AL (n = 21)294.6293.3103.32.22.0 (1.0–8.0)
    CVb (%)45.046.853.532.9
    Ratio (90% CI)0.77 (0.62, 0.96)0.82 (0.65, 1.02)0.84 (0.65, 1.09)0.85 (0.72, 1.00)
Lumefantrine
    TQ + AL (n = 22)196,498.61,043,185.420,445.0197.95.9 (0–12.0)
    AL (n = 21)174,602.3808,244.618,911.0164.74.0 (0–12.0)
    CVb (%)52.361.447.230.0
    Ratio (90% CI)1.13 (0.87, 1.45)1.29 (0.97, 1.73)1.08 (0.86, 1.36)1.20 (1.03, 1.40)
  • a n = 5.

  • b n = 12.

  • c n = 21.

  • d CVb, between-subject variability.