Pharmacokinetic Parameter
Treatment (Mean ± SD)
Test Product
Reference Product
C
max
(µg /ml)
4.26 ±0.62
4.42 ±0.74
AUC
0-t
(µg.h/ml)
53.57 ±17.47
51.88 ±15.08
AUC
0-∞
( µg.h/ml)
57.74 ±18.31
56.00 ±14.96
t
max
(h)
2.21 ±0.62
1.75 ±0.58
t
½e
(h)
12.99 ±4.06
12.66 ±3.46
AUC
0-t
/AUC
0-∞
(%
)
92.39 ±3.67
92.16 ±4.67
K
e
(1/h)
0.0582 ±0.02
0.0586 ±0.02
Table 5:
Pharmacokinetics parameters of modafinil for fasting study (Hikma modafinil 200 mg tablets as a test product versus Provigil® 200 mg tablets as a reference product).
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