TABLE 7.
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 | 67.8 (0.87: 0.67–1.10) | 79.7 (0.87: 0.74–1.03) | 75.9 (0.87: 0.71–1.05) |
| T fasted/R fed | 84.1 (1.08: 0.87–1.34) | 87.3 (1.11: 0.95–1.31) | 13.4 (1.4: 1.18–1.67) |
| T fed/R fasted | 22.8 (0.72: 0.567–0.91) | 13.2 (0.72: 0.60–0.85) | 0.0 (0.57: 0.47–0.69) |
| T fasted/R fasted | 77.7 (0.89: 0.72–1.09) | 88.6 (0.91: 0.77–1.07) | 88.0 (0.92: 0.77–1.11) |
| T fasted/T fed | 52.2 (1.24: 1.01–1.53) | 40.2 (1.27: 1.10–1.48) | 0.8 (1.60: 1.35–1.92) |
| R fasted/R fed | 58.4 (1.24: 0.95–1.53) | 55.1 (1.22: 1.03–1.46) | 4.2 (1.53: 1.25–1.85) |
a
T, test formulation (SUBA-itraconazole); R, reference formulation (Sporanox). A study of 52 subjects was simulated 1,000 times.
b
Gmean, geometric mean of the ratios for the 1,000 studies.