Table 1.
Summary of calculated PK parameters
| PK parameters | Geometric mean | Minimum | Median | Maximum |
|---|---|---|---|---|
| Test formulation: montelukast containing montelukast 5 mg chewable tablets (batch number 1303111) | ||||
| Cmax(ng/mL) | 253.034 | 146.687 | 257.286 | 360.264 |
| AUC0→last (ng·hr/mL) | 1,449.910 | 713.579 | 1,522.708 | 2,735.068 |
| AUC0→inf (ng·hr/mL) | 1,516.558 | 776.492 | 1,590.272 | 2,885.412 |
| Tmax(hr) | 2.36 | 1.50 | 2.50 | 3.25 |
| t1/2 (hr) | 3.84 | 2.11 | 3.89 | 6.62 |
| MRTinf (hr) | 6.34 | 4.03 | 6.35 | 9.35 |
| Residual area (%) | 4.067 | 2.205 | 3.570 | 10.093 |
| Reference formulation: Singulair® pediatric containing montelukast 5 mg chewable tablets (batch number 322559) | ||||
| Cmax (ng/mL) | 257.920 | 133.041 | 261.842 | 409.845 |
| AUC0→last (ng·hr/mL) | 1,431.903 | 702.402 | 1,328.291 | 2,652.547 |
| AUC0→inf (ng·hr/mL) | 1,493.326 | 731.565 | 1,390.724 | 2,747.167 |
| Tmax (hr) | 2.48 | 1.50 | 2.38 | 5.00 |
| t1/2 (hr) | 3.75 | 2.77 | 3.61 | 6.15 |
| MRTinf (hr) | 6.24 | 4.63 | 6.03 | 10.44 |
| Residual area (%) | 3.895 | 2.012 | 3.837 | 8.563 |
Abbreviations: PK, pharmacokinetic; AUC, area under the curve; Cmax, peak plasma concentration; Tmax, time of peak plasma concentration; t1/2, elimination half-life time; hr, hour; MRT, mean residence time.