NCT01085695

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	rabeprazole	10 mg normal tablet
DRUG	rabeprazole	Type 1 granule containing rabeprazole 10 mg
DRUG	rabeprazole	Type 2 granule containing rabeprazole 10 mg
DRUG	rabeprazole	Type 3 granule containing rabeprazole 10 mg

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2010-03-12
• Last updated: 2013-05-13