Study of E3810 for Healthy Japanese Male (Under Fasting Condition)

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

Completed

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

The purpose of this study is to assess bioequivalence after single administration of the following 4 types of formulation: normal 10 mg rabeprazole tablet rabeprazole, and Type 1, Type 2, and Type 3 granule formulation containing rabeprazole 10 mg.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects with homozygous or heterozygous extensive metabolizers of cytochrome P4502C19.

Exclusion criteria

Subjects with allergy

Treatment and study plan

rabeprazole

Drug

10 mg normal tablet

Primary outcomes

The following pharmacokinetic parameters are calculated: maximum drug concentration (Cmax) in plasma; area under the plasma concentration time curve (AUC)

Time frame: One day

Secondary outcomes

Vital signs, clinical laboratory screens of blood and urine, adverse event monitoring, adverse drug reaction monitoring

Time frame: 13 days

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Mar 12, 2010
Registry last updated: May 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed