This is an open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, oral bioequivalence study.
The study was an open label, balanced, randomized, two-treatment, two-period, two sequence,single dose, crossover, oral bioequivalence study of Donepezil Hydrochloride tablets 10mg of Dr. Reddy's Laboratories Limited, India comparing with that of ARICEPT® (containing Donepezil Hydrochloride) tablets 10mg of Pfizer Inc, New York, 10017 in healthy, adult, human subjects under fed condition. 28 subjects are enrolled in the study, 3 subjects are withdrawn from the study and 25 subjects are completed the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Donepezil Hydrochloride Tablets 10 mg
Aricept 10 mg Tablets
Bioserve Clinical Research Private Limited
Hyderabad, Andhra Pradesh, India
Area under curve (AUC)
Time frame: Pre-dose 0.5,0.75,1,1.5,2,2.5,3,3.5,4,4.5,5,5.5,6,7,8,9,10,12,16,24,36,48,72,96,120,144,168,192,216,240 and 264 hours post-dose
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