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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: rabeprazole

• Registration Number: NCT01085708
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-11
• Study First Submitted QC: 2010-03-11
• Study First Posted: 2010-03-12
• Study Start: 2010-04
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-09
• Last Update Submitted: 2013-05-09
• Last Update Posted: 2013-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	rabeprazole	-
3	rabeprazole	-
4	rabeprazole	-
1	rabeprazole	-

Primary Outcome Measures

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