Parameters Mean ± DS
Test Product Reference Product
Tmax (h) 2.5 ± 1.5 3;0± 2;0
Cmax (ng/ml) 460.5 ± 170.9 440.6 ± 227.4
AUC0→24 (ng/h.ml) 3251.6 ± 1221.8 3162.5 ± 1537.6
AUC0→∞(ng/h.ml) 3284.9 ± 1270.0 3196.5 ± 1546.8
Ke (1/h) 0.204 ± 0.144 0.203 ± 0.163
t1/2 (h) 3.4 ± 1.6 3.4 ± 1.4
Table 2: Average of the pharmacokinetic parameters of Montelukast tablets after a 10 mg single-dose administration of the Test and Reference products to 20 volunteers.
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