TABLE 4.
Summary of statistical analysis of ritonavir pharmacokinetic parameters following administration of 400 mg or 100 mg BID ritonavir in the absence (Day 20) or presence (Day 30) of 200 mg BID voriconazole or placebo (Studies A and B)
| Pharmacokinetic parameter | Arithmetic mean (SD)
|
Geometric mean ratio (day 30/day 20 [%])b (90% CI) | |||
|---|---|---|---|---|---|
| 400 mg BID ritonavir alone | 100 mg BID ritonavir alone | With placebo | With 200 mg BID voriconazole | ||
| Study A | |||||
| Group 1 (n = 14) | |||||
| AUC0-12 (μg · h/ml) | 68.0 (21.0) | 65.9 (28.2) | 94.7 (76.9, 116.8) | ||
| Cmax (μg/ml) | 10.7 (3.19) | 10.4 (3.84) | 97.1 (81.9, 115.0) | ||
| Cmin (μg/ml)a | 4.7 (2.2-7.8) | 4.3 (0.92-9.3) | |||
| Tmax (h)a | 1.5 (1-9) | 1 (1-5) | |||
| Group 2 (n = 15) | |||||
| AUC0-12 (μg · h/ml) | 65.3 (18.4) | 58.4 (17.2) | 89.2 (80.3, 99.2) | ||
| Cmax (μg/ml) | 10.5 (3.43) | 10.2 (3.95) | 95.7 (84.9, 107.8) | ||
| Tmax (h)a | 1 (1-5) | 1 (1-4) | |||
| Study B (n = 17) | |||||
| AUC0-12 (μg · h/ml) | 7.81 (3.87) | 6.43 (2.41) | 86.2 (73.8, 100.7) | ||
| Cmax (μg/ml) | 1.41 (0.721) | 0.992 (0.299) | 75.7 (61.2, 93.7) | ||
| Cmin (μg/ml)a | 0.32 (0.02-0.81) | 0.25 (0.04-0.67) | |||
| Tmax (h)a | 1 (1-5) | 3 (1-5) | |||
a
Median (range).
b
Day 20, ritonavir alone; day 30, ritonavir plus voriconazole/placebo.