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

NCT01506752 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-06-27

No results posted yet for this study

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).

Conditions

  • Healthy Adult

Interventions

DRUG

Donepezil Hydrochloride

improved orally disintegrating E2020 10 mg tablet without water.

DRUG

Donepezil Hydrochloride

current orally disintegrating E2020 10 mg tablet without water.

DRUG

Donepezil Hydrochloride

improved orally disintegrating E2020 10 mg tablet with water.

DRUG

Donepezil Hydrochloride

current orally disintegrating E2020 10 mg tablet with water

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hiroki Shimizu · Eisai Co., Ltd.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
44 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Japan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01506752 on ClinicalTrials.gov