Table 3.
Mean ketoconazole pharmacokinetic parameters on day 7 following treatment with ketoconazole 200 mg bid alone and in combination with darunavir 400 mg bid and darunavir/ritonavir 400/100 mg bid
| Parameter (mean ± SD) n | Ketoconazole + darunavir 6 | Ketoconazole (reference) 15 | Ketoconazole + darunavir/ritonavir (test) 17 | LSM ratio: ketoconazole + darunavir/ritonavir vs. ketoconazole alone (90% CI) 15 |
|---|---|---|---|---|
| Cmin (ng ml−1) | 692 ± 565 | 831 ± 794 | 5 354 ± 1 627 | 9.68 (6.44, 14.55) |
| Cmax (ng ml−1) | 5 458 ± 747 | 5 311 ± 2 018 | 10 501 ± 2 524 | 2.11 (1.81, 2.44) |
| AUC12h (ng h−1 ml−1) | 35 292 ± 7 209 | 33 098 ± 16 014 | 94 343 ± 25 129 | 3.12 (2.65, 3.68) |
| tmax (h)* | 3.0 (2.0–3.0) | 3.0 (1.0–4.0) | 3.0 (1.0–5.0) | – |
*
median (range).