Table 2.
Summary statistics and the GMR (oral granules formulation/chewable tablet formulation) with 90% CIs for AUC0-∞ (ng·hr/mL) and Cmax (ng/mL) of montelukast after administration of single 4-mg doses (fasted) (Study 1 and Study 2)
| Study 1 (Formulation BC Study) |
Study 2 (Final Market Image BE Study) |
|||
|---|---|---|---|---|
| OG Fasted (N = 24) | CT Fasted (N = 24) | OG Fasted (N = 30) | CT Fasted (N = 30) | |
| AUC0-∞ (ng·hr/mL) | ||||
| Geometric mean ± SD | 1,223.1 ± 342.3 | 1,208.3 ± 467.4 | 1,148.5 ± 392.4 | 1,210.3 ± 412.3 |
| GMR (90% CI) | 1.01 (0.92, 1.11) | 0.95 (0.91, 0.99) | ||
| Cmax (ng/mL) | ||||
| Geometric mean ± SD | 198.8 ± 53.8 | 201.7 ± 91.6 | 175.4 ± 59.2 | 190.0 ± 64.3 |
| GMR (90% CI) | 0.99 (0.86, 1.13) | 0.92 (0.84, 1.01) | ||
BC = biocomparison; BE = bioequivalence; CI = confidence interval; CT = chewable tablet; GMR = Geometric mean ratio (OG formulation/CT formulation); OG = oral granules; SD = between-subject standard deviation.