NCT01504516

Bioequivalence Study for Donepezil Hydrochloride Tablets 10 mg Under Fed Condition

Open Label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Oral Bioequivalence Study of Donepezil Hydrochloride Tablets 10mg With ARICEPT® (Containing Donepezil Hydrochloride) Tablets 10mg in Healthy, Adult, Human Subjects Under Fed Condition.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is an open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, oral bioequivalence study.

Detailed description

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10017 in healthy, adult, human subjects under fed condition. 28 subjects are enrolled in the study, 3 subjects are withdrawn from the study and 25 subjects are completed the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Donepezil Hydrochloride	Donepezil Hydrochloride Tablets 10 mg
DRUG	Aricept	Aricept 10 mg Tablets

Timeline

• Start date: 2009-10-01
• Primary completion: 2009-11-01
• Completion: 2009-12-01
• First posted: 2012-01-05
• Last updated: 2012-01-06

Locations

1 site across 1 country: India