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

Phase 1

Completed

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

• Registration Number: NCT01506739
• Lead Sponsor: Eisai Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-01
• Study First Submitted: 2012-01-06
• Study First Submitted QC: 2012-01-09
• Last Update Submitted: 2012-01-09
• Study First Posted: 2012-01-10
• Last Update Posted: 2012-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Donepezil Hydrochloride	-
3	Donepezil Hydrochloride	-
2	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