TABLE 6.
Percentage of bioequivalent studies of 50 mg of SUBA-itraconazole versus 100 mg of Sporanox in fed and fasted states
| Treatmenta | % of bioequivalent studies (Gmean: 90% CI)b |
||
|---|---|---|---|
| AUC0–∞ | AUC0–120 | Cmax | |
| T fed/R fed | 60.8 (0.88: 0.61–1.27) | 71.0 (0.88: 0.69–1.13) | 65.6 (0.88: 0.66–1.184) |
| T fasted/R fed | 67.8 (1.08: 0.76–1.49) | 74.6 (1.11: 0.86–1.43) | 22.7 (1.41: 1.09–1.85) |
| T fed/R fasted | 28.5 (0.72: 0.52–1.03) | 22.3 (0.72: 0.56–0.92) | 1.7 (0.57: 0.44–0.74) |
| T fasted/R fasted | 68.3 (0.90: 0.67–1.23) | 78.2 (0.91: 0.71–1.16) | 75.9 (0.91: 0.70–1.16) |
| T fasted/T fed | 48.4 (1.24: 0.91–1.67) | 42.7 (1.27: 1.00–1.59) | 5.3 (1.61: 1.24–2.09) |
| R fasted/R fed | 51.2 (1.21: 0.83–1.75) | 51.6 (1.23: 0.94–1.62) | 10.6 (1.55:1.16–2.09) |
a
T, test formulation (SUBA-itraconazole); R, reference formulation (Sporanox). A study of 24 subjects was simulated 1,000 times.
b
Gmean, geometric mean of the ratios for the 1,000 studies.