TABLE 5.
Summary of pharmacokinetic parameters for ketoconazole in study arm 2 (n = 12)
| Parameter | GM (%CV)a
|
GMR (90% CI)b | |
|---|---|---|---|
| Period 1 (ketoconazole alone) | Period 2 (ketoconazole + saquinavir + ritonavir) | ||
| Cmax (μg/ml) | 3.86 (28.9) | 5.59 (29.1) | 1.45 (1.32-1.59) |
| AUC0-24 (μg·h/ml) | 24.3 (36.4) | 65.2 (32.1) | 2.68 (2.46-2.93) |
| C24 (ng/ml) | 87.4 (79.7) | 1,100 (47.8) | NA |
| Tmax (h) | 2.5 (2.0-5.0) | 3.5 (2.0-4.0) | NA |
| t1/2 (h) | 4.3 (2.1-7.0) | 10.7 (6.7-18.5) | NA |
| CLss/F (liter/h) | 8.22 (36.4) | 3.07 (32.1) | NA |
a
GM, geometric mean.
b
GMR, geometric mean ratio of period 2/period 1. NA, not assessed.