Parameters
Mean ± DS
Test Product
Reference Product
T
max
(h)
2.5 ± 1.5
3;0± 2;0
C
max
(ng/ml)
460.5 ± 170.9
440.6 ± 227.4
AUC
0→24
(ng/h.ml)
3251.6 ± 1221.8
3162.5 ± 1537.6
AUC
0→∞
(ng/h.ml)
3284.9 ± 1270.0
3196.5 ± 1546.8
K
e
(1/h)
0.204 ± 0.144
0.203 ± 0.163
t
1/2
(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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