NCT01439230

Donepezil 10 mg Tablets Under Fasting Conditions

Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Donepezil 10 mg Tablet and Aricept® (Reference) Following a 10 mg Dose in Healthy Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to compare the rate and extent of absorption of donepezil 10 mg tablet (test) versus Aricept® (reference), administered as a 1 x 10 mg tablet under fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Donepezil	10 mg Tablet
DRUG	Aricept®	10 mg Tablet

Timeline

• Start date: 2007-06-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2011-09-23
• Last updated: 2011-09-23

Locations

1 site across 1 country: Canada