TABLE 5.
Model-predicted food effects on itraconazole noncompartmental analysis metrics using bioequivalent dose for Sporanox (100 mg) and SUBA-itraconazole (58 mg)
| Drug | Fed/fasted state | Geometric means (90% CI) for: |
||
|---|---|---|---|---|
| AUC0–∞ (ng/ml · h) | Cmax (ng/ml) | Tmax (h) | ||
| Sporanox | Fed | 675.39 (653.22–701.53) | 51.37 (50.01–53.12) | 6.83 (6.72–6.92) |
| Fasted | 831.52 (805.94–860.94) | 78.31 (75.72–80.84) | 3.86 (3.76–3.94) | |
| Fed/fasted (%) | 81.22 (77.82–84.96) | 65.60 (63.08–68.76) | 176.94 (172.57–182.10) | |
| SUBA-itraconazole | Fed | 653.60 (634.83–671.21) | 50.23 (48.59–51.74) | 6.83 (6.72–6.94) |
| Fasted | 833.52 (806.99–862.55) | 81.18 (78.83–83.27) | 3.87 (3.80–3.93) | |
| Fed/fasted (%) | 78.41 (74.99–81.71) | 61.88 (59.10–64.15) | 184.33 (176.66–180.41) | |