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A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Postprandial Condition)

NCT ID: NCT01085708

Last Updated: 2013-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-05-31

Brief Summary

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The purpose of this study is to assess pharmacokinetics of rabeprazole under postprandial condition.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

rabeprazole

Intervention Type DRUG

10 mg normal tablet

2

Group Type EXPERIMENTAL

rabeprazole

Intervention Type DRUG

Type 1 granule containing rabeprazole 10 mg

3

Group Type EXPERIMENTAL

rabeprazole

Intervention Type DRUG

Type 2 granules containing rabeprazole 10 mg

4

Group Type ACTIVE_COMPARATOR

rabeprazole

Intervention Type DRUG

Type 3 granules containing rabeprazole 10 mg

Interventions

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rabeprazole

10 mg normal tablet

Intervention Type DRUG

rabeprazole

Type 1 granule containing rabeprazole 10 mg

Intervention Type DRUG

rabeprazole

Type 2 granules containing rabeprazole 10 mg

Intervention Type DRUG

rabeprazole

Type 3 granules containing rabeprazole 10 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Subjects with homozygous or heterozygous extensive metabolizers of cytochrome P4502C19

Exclusion Criteria

Subjects with allergy
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eisai Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kai Shibata

Role: STUDY_DIRECTOR

Clinical Research Center, Eisai, Co., Ltd

Other Identifiers

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E3810-J081-034

Identifier Type: -

Identifier Source: org_study_id

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