A Bioequivalence Study Comparing Improved Versus Current Orally Disintegrating E2020 10 mg Tablet in Healthy Japanese Adult Males

Phase 1

Completed

• Conditions: Healthy Adult
• Interventions: Drug: Donepezil Hydrochloride

• Registration Number: NCT01506752
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

The purpose of this study is to investigate the bioequivalence of improved and current orally disintegrating E2020 10 mg tablets as a single dose in Japanese healthy adult males for each of two administration methods (with/without water).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-01
• Study First Submitted: 2012-01-06
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-10
• Last Update Submitted: 2012-06-25
• Last Update Posted: 2012-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
E2020 improved 10 mg without water	Donepezil Hydrochloride	-
E2020 improved 10 mg with water	Donepezil Hydrochloride	-
E2020 current 10 mg without water	Donepezil Hydrochloride	-
E2020 current 10 mg with water	Donepezil Hydrochloride	-

Primary Outcome Measures

Name	Time	Method
PK Parameter Cmax, calculated from plasma E2020 concentration by a non-compartmental analysis, will be evaluated.	Up to 168 hrs after administration
PK Parameter AUC(0-168), calculated from plasma E2020 concentration by a non-compartmental analysis, will be evaluated.	Up to 168 hrs after administration