Parameter (unit)
Test Product
Reference Product
C
max
(ng/mL)
4454.1 ± 3684
4415.9 ± 2705
AUC
0-t
(ng*h/mL)
11935 ± 6315
11354 ± 5327
AUC
0-∞
(ng*h/mL)
12846± 6092
12112 ± 5224
T
max
(h)
1.7 ± 0.8
1.4 ± 0.7
K
e
(1/h)
0.463 ± 0.291
0.496 ± 0.227
Table 4:
Pharmacokinetic Parameters for Test Product Irbesartan (Tecnoquímicas S.A.) and Reference Product (Aprovel
®
) followed by a 300 mg Single Oral Dose Under Fasting.
