Table 4.
Summary statistics and the GMR (Fed/Fasted) with 90% CIs for AUC0-∞ (ng·hr/mL) and Cmax (ng/mL) of montelukast after administration of single 4-mg doses of the oral granules formulation with and without food (Study 1 and Study 2)
| Study 1 (Formulation BC Study) |
Study 2 (Final Market Image BE Study) |
|||
|---|---|---|---|---|
| OG with Appelsauce†(N = 24) | OG Fasted (N = 24) | OG with High-fat Meal‡(N = 30) | OG Fasted (N = 30) | |
| AUC0-∞ (ng·hr/mL) | ||||
| Geometric mean ± SD | 1,225.7 ± 528.9 | 1,223.1 ± 342.3 | 1,191.8 ± 380.3 | 1,148.5 ± 392.4 |
| GMR (90% CI) | 1.00 (0.92, 1.10) | 1.04 (0.99, 1.09) | ||
| Cmax (ng/mL) | ||||
| Geometric mean ± SD | 182.8 ± 78.2 | 198.8 ± 53.8 | 112.8 ± 26.2 | 175.4 ± 59.2 |
| GMR (90% CI) | 0.92 (0.80, 1.06) | 0.64 (0.59, 0.71) | ||
†
OG administered on 2 teaspoons of applesauce.
‡
OG administered 5 minutes after consumption of a high-fat breakfast.
BC = biocomparison; BE = bioequivalence; CI = confidence interval; CT = chewable tablet; GMR = Geometric mean ratio (fed/fasted); OG = oral granules; SD = between-subject standard deviation.