This study investigated the relative bioavailability (rate and extend of absorption) of Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg by Teva Pharmaceuticals, USA with that of Aricept® Orally Disintegrating Tablets, Manufactured and Marketed by Eisai Inc., following a single oral dose (1 x 10 mg orally disintegrating tablet) in healthy adult subjects administered under non-fasting conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
26
10 mg Orally Disintegrating Tablet
10 mg Orally Disintegrating Tablet
PRACS Institute, Ltd.
East Grand Forks, Minnesota, United States
Cmax of Donepezil.
Bioequivalence based on Donepezil Cmax (maximum observed concentration of drug substance in plasma).
Time frame: Blood samples collected over a 72 hour period.
AUC0-t of Donepezil.
Bioequivalence based on Donepezil AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Time frame: Blood samples collected over a 72 hour period.
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