TABLE 8.
Secondary parameters describing the population pharmacokinetics of lumefantrine and desbutyl-lumefantrinea
| Drug and secondary parameter | Median value (range) for group |
|||
|---|---|---|---|---|
| 3 days |
5 days |
|||
| Nonpregnant | Pregnant | Nonpregnant | Pregnant | |
| Lumefantrine | ||||
| Tmax (h) | 7.95 (4.81–15.2) | 7.86 (4.47–16.7) | 7.72 (5.54–11.7) | 8.66 (4.76–14.0) |
| Cmax (ng/ml) | 6,170 (2,790–14,400) | 6,290 (4,140–10,900) | 7,320 (3,010–16,000) | 6,600 (2,890–12,300) |
| AUC0–60 (h · μg/ml) | 531 (267–1,250) | 586 (321–887) | 933 (374–2,030) | 853 (381–1,650) |
| Half-life (days) | 3.41 (3.22–3.69) | 3.52 (3.22–3.87) | 3.45 (3.24–3.92) | 3.57 (3.33–3.97) |
| Day 7 concn (ng/ml) | 541 (333–1,360) | 665 (353–818) | 1,900 (576–2,870) | 1,280 (596–2,770) |
| Tc>280 (days) | 9.83 (7.63–14.5) | 10.6 (6.98–12.5) | 14.1 (9.03–17.8) | 13.5 (9.63–17.3) |
| Desbutyl-lumefantrine | ||||
| Tmax (h) | 16.7 (9.0–29.9) | 19.8 (10.1–32.1) | 13.9 (7.39–29.6) | 14.6 (8.11–24.9) |
| Cmax (ng/ml) | 42.7 (15.3–74.6) | 51.4 (22.3–104) | 56.2 (27.0–150) | 75.5 (26.8–127) |
| AUC0–60 (h · μg/ml) | 8.26 (3.09–15.9) | 12.9 (6.41–24.5) | 14.4 (5.98–41.8) | 20.4 (10.4–35.5) |
| Half-life (days) | 8.93 (7.41–10.9) | 11.2 (8.15–16.0) | 9.37 (7.75–12.1) | 11.2 (9.39–13.7) |
a
Tmax is the time to reach the maximum concentration (Cmax). AUC0–60 is the total exposure from the first dose to day 60.