NCT01506739

A Bioequivalence Study of Film-coated Tablet and Dry Syrup 1% Form for E2020 in Healthy Japanese Adult Males

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 44 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to confirm bioequivalence between E2020 dry syrup 1% form (0.5 g), given either with 200 mL of water or suspended in 20 mL of water, and E2020 film-coated tablet (5 mg) in Japanese healthy adult males.

Conditions

• Healthy Adult

Interventions

Type	Name	Description
DRUG	Donepezil Hydrochloride	Drug E2020 film-coated tablet: E2020 film-coated tablet (5mg) orally administered in a single dose with 200 mL water.
DRUG	Donepezil Hydrochloride	Drug E2020 dry syrup 1% form (suspended): E2020 dry syrup 1% (0.5 g) will be orally administered in a single dose after suspended in 20 ml water.
DRUG	Donepezil Hydrochloride	Drug E2020 dry syrup 1% form: E2020 dry syrup 1% (0.5 g) will be orally administered in a single dose with 200 mL water.

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2012-01-10
• Last updated: 2012-01-10

Locations

1 site across 1 country: Japan