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

NCT01085708 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2013-05-13

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

rabeprazole

10 mg normal tablet

DRUG

rabeprazole

Type 1 granule containing rabeprazole 10 mg

DRUG

rabeprazole

Type 2 granules containing rabeprazole 10 mg

DRUG

rabeprazole

Type 3 granules containing rabeprazole 10 mg

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kai Shibata · Clinical Research Center, Eisai, Co., Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-05-31
Completion
2010-05-31

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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 NCT01085708 on ClinicalTrials.gov