Table 3 Summary of calculated PK parameters
Parameters (unit) | Test montelukast | Reference singular® | ||
|---|---|---|---|---|
Efficacy results summary | ||||
As geometric means (ranged for) Cmax and AUCRatio | ||||
Cmax (ng/mL) | 428.910 | 381.900 | ||
176.680 | 783.900 | 80.000 | 792.150 | |
AUC0→Last (ng h/mL) | 2731.650 | 2437.870 | ||
1386.330 | 6884.470 | 682.170 | 7495.260 | |
AUC0→inf (ng h/mL) | 2825.270 | 2526.380 | ||
1445.510 | 7597.020 | 737.910 | 7963.160 | |
As medians (ranges) for Tmax, and t1/2 | ||||
Tmax (h) | 3.50 | 3.50 | ||
2.00 | 6.00 | 1.50 | 5.00 | |
t1/2 (h) | 4.10 | 4.49 | ||
2.42 | 6.36 | 2.20 | 5.71 | |
Parameter | Point estimate (ratio of geometric mean %) | Lower limit % | Upper limit % | CV % |
|---|---|---|---|---|
Bioequivalence results summary | ||||
Cmax | 112.169 | 101.447 | 124.024 | 23.58660 |
AUC0→Last | 111.939 | 101.285 | 123.714 | 23.47754 |
AUC0→inf | 111.711 | 101.119 | 123.413 | 23.38104 |