NCT01504503

Bioequivalence Study for Donepezil Hydrochloride 10 mg Tablets Under Fasting 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 10 mg in Healthy, Adult, Human Subjects Under Fasting Condition.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (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 10 mg of Dr. Reddy's Laboratories Limited, India comparing with that of ARICEPT® (containing Donepezil Hydrochloride) tablets 10 mg of Pfizer Inc, New York, 10017 in healthy, adult, human subjects under fasting condition. 28 subjects are enrolled in the study, and 26 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