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

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

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

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

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