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

NCT01506739 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-01-10

No results posted yet for this study

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

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.

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
2011-03-31
Primary Completion
2011-05-31
Completion
2011-05-31

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 NCT01506739 on ClinicalTrials.gov